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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

« Changes in Papers | Main | A Close Look at Receptor Signaling »

February 26, 2014

The Instructive Case of Galena Biopharma

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Posted by Derek

If you're in the mood for another reason why you should always be cautious about your biopharma investments, look no further than Galena Biopharma (GALE to its many clueless fans). I've been following this story over the last couple of weeks, and what a mess it is. Galena is a small company in Oregon with a few assets, including a cancer vaccine candidate. Its stock hovers in the low single digits, as is appropriate. But in December and January, it began to trade up, and up. From $2/share to $4. Then to $6, and then higher. And this on no particular news or change in the company's prospects, which for a stock like this is often a sign of "momentum" players getting involved. "Momentum" investing is a fancy name for "I'm buying this because it's going up", and the people who do this sort of thing are understandably anxious for you to buy some, too. They're also very, very unwilling to hear about anything that might cause the stock to go back down, because the proper direction for stocks, we must remember, is up. They only go down because of evil short bashers; everyone knows this.

Adam Feuerstein of TheStreet.com delivered a great big dose of that evil stuff (known to the rest of us as "reality") on February 12 with this article, which showed why the stock had been rising. The company was paying a PR firm to beat the drums for it, said drum-beating going as far as having people post multiple supposedly-independent articles on sites like Seeking Alpha under a list of pseudonyms.

An outfit called the "DreamTeam Group" was hired for the promotion. They run a stable of stock-touting web sites, full of wonderful tales about the companies that are paying them to say these wonderful things. And they spread the word on other sites (as above), and on Twitter, by e-mail and whatever means come to hand. If carrier pigeons come back into fashion, you can count on one fluttering down with a hot stock tip for you. And if you're greedy and stupid, you could see all this hype and convince yourself that a Great Opportunity is spawning right in front of you - why, all these people are buzzing about this hot little company, and money is right there for the taking. The only reason not to get in on a deal like this would be a lack of vision.

Galena's insiders do not lack vision. Indeed, they have proven beyond any doubt that money was in fact there for the taking. GALE peaked at nearly $8/share, but its directors and officers were unloading millions of dollars worth of shares into that market. And who could blame them? These are legal financial transactions between consenting adults, and if one set of those adults know what's going on and the other set doesn't, well, it's that kind of world, isn't it? A look at any jungle will show the larger predators eating the smaller ones, and God knows the Street isn't any different.

Yesterday GALE closed at about $4, and many of its "investors" are hopping mad about that, as a look at Feuerstein's mailbag will show. But here are some cynical people who figure that the company is actually worth about seventy-two cents a share. Reasonable observers can disagree about that figure. But if you want to argue that the company is cruelly undervalued at $4, you are probably not a reasonable observer. Or you bought at $7. Same thing.

Update: if you'd like to know why people are so skeptical of the prospects for Galena's vaccine, look no further than this comment. It's right on target.

Comments (64) + TrackBacks (0) | Category: Business and Markets | The Dark Side


COMMENTS

1. Anonymous on February 26, 2014 9:34 AM writes...

Well, I have neither admiration nor sympathy for greedy speculators that have no clue what they are doing: A fool and his money are soon parted.

Evolution by natural selection at it's finest!

Permalink to Comment

2. Hap on February 26, 2014 9:43 AM writes...

I guess that's pretty bad news for its employees - if your company is hiring a firm to astroturf your company's stock and the people in the company who have it (and unlike you, can probably actually sell it) are selling, then that says pretty clearly what management thinks of its prospects and what it's selling. It probably also sucks for the people who actually invested in it for the long-term - it's nice to know that you're invested in what looks like a pump-and-dump scheme.

Investing in biopharma seems like playing Russian roulette with a semiautomatic pistol (and no, the clip isn't empty) - you can lose when the candidate fails (most of the time) or you can fail because you found a pump-and-dump scheme. If neither of those happen, and the stock dilutions don't kill you, you might get out OK if your company is bought or actually gets a product to market. (Of course, none of these cases work out for the people who work there.) So, given that investing in these companies is not for the sane, and working for them might not be either (though it might be fun, it's probably not lucrative), where are the drug candidates in big pharma going to come from again?

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3. Anonymous on February 26, 2014 9:51 AM writes...

@2: Basically it comes down to a short-term mentality of taking value from others, rather than take the more difficult and courageous route of creating value in the long term. It can only end badly for everyone.

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4. Philip on February 26, 2014 10:01 AM writes...

@Hap, I am a small biopharma investor, and consider myself sane. I know I am not the best judge of my own sanity, but it is all I have.

What is not sane is investing more than you can afford to lose in small biohparma or being wed to the stock. If the stock runs up and the insiders start to sell, run for the hills (VVUS for example). If a stock goes up on no real (ie, data supported) news, sell, you can buy back on the coming dip or at worst make a nice profit (see MNKD over the last year). If you are confident that you have interpenetrated the data correctly and others (Adam and or Derek) have not, go for it. The worst that can happen is you lose money you could afford to lose. The best is that the FDA approves the drug (see ARNA) and you triple your money.

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5. Anonymous on February 26, 2014 10:06 AM writes...

@4: The only way you can beat the market is if:

a) you know more than the market - unlikely; or

b) you are luckier than the market - possible in the short term, but no more likely than being unlucker than the market.

Still feeling confident about your clever strategy?

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6. entropygain on February 26, 2014 10:19 AM writes...

Coincidentally, I've been getting calls almost every day now from some guys with a brooklyn accent out of a bucket shop hawking the latest hot biotech stock. Haven't stayed on the line long enough to hear which one. Sheesh I wish the do-not-call list stuff worked....

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7. Philip on February 26, 2014 10:20 AM writes...

@Anonymous, yes I am:

a) You can know more than the market, if the market does not understand the company and you have taken the time to. This opportunity does not happen very frequently. ARNA is an example of where the market underestimated the company. Both in terms of Belviq approval and the underlying technology that allowed its development. VVUS is an example of the market overestimating the company. The market thought that having the most effective weight loss drug on the market was more important than having a safe weight loss drug and one without common side effects such as tingling in the hands and feet. VVUS also had other problems.

b) What is the old saying about luck favoring the well prepared? It takes time and effort to find the under valued and you can still be wrong. That is why you never bet more than you can afford to lose. Same goes for the race track or Vegas.

Also do the math. If you win 50% and those wins triples your money, you are doing OK.

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8. Anonymous on February 26, 2014 10:23 AM writes...

@7: "IF" is a big word. Good luck then.

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9. Anonymous on February 26, 2014 10:29 AM writes...

PS.7: Interestingly, your investment strategy is quite the opposite of Warren Buffet's. I guess he has just been consistently very lucky?

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10. biotechtoreador on February 26, 2014 10:30 AM writes...

Bravo!

This type of shameful stock manipulation should put GALE executives in jail, but obviously won't.

What's even more galling, at least to me, is that the same goes on every day at Wall Street investment banks whose analysts issue BUY ratings on stocks solely for the purpose of procuring investment banking fees (which can be quite substantial), in clear violation of FINRA reg 2711.

In the 1990s this analysts led away from their offices in handcuffs: today it gets them in the drivers seat of an Aston Martin.

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11. BuyersStrike! on February 26, 2014 10:30 AM writes...

@Derek

Thanks for the link. Whenever I see these cult stocks, and the longs rationalizing their continued shareholders, it brings to mind one of the classics of social psychology "When Prophecy Fails" by Festinger.

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12. jawn on February 26, 2014 10:32 AM writes...

@1, @"Evolution by natural selection at it's finest!"

I don't usually make a big deal out of grammatical mistakes, but when ridiculing idiots you should really use correct grammar or you look like one yourself.

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13. Anonymous on February 26, 2014 10:32 AM writes...

I've been following Prana's science for years, waiting for them to fold. Can't believe they are still managing to string investors along with their silly clioquinol stuff.

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14. Anonymous on February 26, 2014 10:35 AM writes...

@12: Yes, I added an incorrect apostrophe while typing fast, but chill, it's just a blog, not a publicastion in Nature!

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15. Hap on February 26, 2014 10:38 AM writes...

4: Sorry to unfairly impugn your sanity. Those conditions (don't bet more than you can lose, know lots about the company and its products) must be met by someone (else VCs would get hosed too), but they don't seem to be met very often, and they are still pretty contingent (because even candidates that look good fail, lots).

If it's possible to win, but not often, then eiether the payouts must be good, or there won't be much investment (or you do what Galena did, but I'm assuming a business that relies on dumb investors with lots of money won't be around long).

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16. Anonymous on February 26, 2014 10:38 AM writes...

@12: "publication", SORRY!

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17. Magrinho on February 26, 2014 10:41 AM writes...

I agree with Philip.

You can make money in biotech by essentially knowing more than the market. Study the numbers, challenge the conventional wisdom and don't listen to analysts (their business is selling stock). Learn the science and study the financials. It is a LOT of hard work but rewarding.

VVUS is a perfect example, imo. It's been a dead man walking for 18 months.

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18. Hap on February 26, 2014 10:46 AM writes...

I'm guessing also 1) don't invest money you don't have and 2) have enough time to wait out the market (hence 1).

Permalink to Comment

19. jawn on February 26, 2014 10:47 AM writes...

@1, 14, 16:

Sorry if I got under you're skin!

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20. bigredbruce on February 26, 2014 10:48 AM writes...

Fortunately I bought at $2.40 so was quite happy to leave at $4. What do they say about pigs geing slaughtered?

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21. Vader on February 26, 2014 11:04 AM writes...

#3, #4.

Agree. You have a fair shot at making money on the market if you take the time and effort to build up the necessary asymmetric information.

The point is that this does, in fact, take time and effort. As with every other form of knowledge generation. Also, a willingness to bear the risk that your knowledge isn't as asymmetric as you thought.

It's also perfectly fair and in the public interest. You did the work and you bore the risk of being wrong. You're entitled to the profits, if any. Meanwhile, by acting on your information in making your stock selections, you've helped nudge the market in the direction indicated by your knowledge, by which I mean that the price of the stock is slightly adjusted in a direction more likely to be consistent with reality.

I don't think anyone should have a problem with it.

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22. Anonymous on February 26, 2014 11:05 AM writes...

@19: No worries, and I saw what you did there, ho ho! ;-)

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23. Anonymous on February 26, 2014 11:13 AM writes...

@21: And the net gain for society as a whole, of winning at the expense of other investors, is what exactly?

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24. Philip on February 26, 2014 11:14 AM writes...

@Anonymous 8 and 9: "If" is a big word, but so far my investment strategy has worked for me. It could all come crashing down today. I once watched ARNA crash about 25% in a minute on no news. When I confirmed it was on no news, I bought more.

As for investing like Buffet, I do not have Buffet type money, and therefore cannot invest/buy companies. Like Buffet I look for value and if the company has a product that will sell in the future.

My strategy of being a trader on no news, and a holder through news is a bit odd, but does go along with Buffet's “Be Fearful When Others Are Greedy and Greedy When Others Are Fearful” approach.

@17 Magrinho, thanks for the support. Most people here seem very risk adverse.

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25. Lane Simonian on February 26, 2014 11:21 AM writes...

I agree with #13 about Prana. Feuerstein has written some cautionary stories on it as well and received some nasty responses. Prana at least produced one slight positive result in a Phase 2 clinical trial for Huntington's disease: an improvement in executive function during the early stage of the disease. And based on its past reports, this is likely what will come out of its most recent Alzheimer's clinical trial as well.

I have noticed on biotech stocks, the "pumpers" do a lot of manipulation of facts to try to create a stampede to the stock. What particularly bothers me, though, is when a neuroscientist like Tanzi becomes a stockbroker for his "own" company apparently sending out "historic" tweets and all.

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26. watcher on February 26, 2014 11:21 AM writes...

Can someone explain why this isn't either insider trading or deliberate stock manipulation? Shouldn't the SEC investigate, with the any offenders be fined, etc.

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27. Hap on February 26, 2014 11:48 AM writes...

23: If the game's not rigged, then people who don't think enough, or well enough, lose their money to people who do. The people who can think well and do can use the money better, and hopefully invest the money into things more likely to be useful than the things people who don't think invest their money in, like this company, apparently.

26: I don't think it's insider trading, because they could be trading on the price increase - of course, the price is increasing because they're paying people to (mis)represent their stock. I would think that's stock manipulation, but I don't know.

Permalink to Comment

28. biotechtoreador on February 26, 2014 12:29 PM writes...

and another shameful example: http://observer.com/2014/02/tough-to-swallow-paper-trail-behind-breakthrough-leads-to-penny-stock-profiteers/

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29. watcher on February 26, 2014 12:34 PM writes...

27: But, they initiated the anonymous "good will" campaign to the company's favor, which was not known to anyone except company insiders at the time, which gave the intended result of driving the price up due to buying by those who don't look further than those positive presentations (eg, where's the meat). A definition of insider trading is to make stock moves by those "in the know" based on information that was not publically known at the time.

So, why is this not insider trading?

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30. Hap on February 26, 2014 12:48 PM writes...

Is the Ahn who's CEO of Galena the same one who ran Rexahn (of "Sketchy Biotech Day" fame -http://pipeline.corante.com/archives/2010/04/16/a_landmark_in_clinical_trial_data_interpretation.php)? If so, then I'm guessing some investors should probably have seen this coming.

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31. biotechtoreador on February 26, 2014 1:08 PM writes...

"Is the Ahn who's CEO of Galena the same one who ran Rexahn"

Yup, one and same!

King Rex as company name, fantastic.

Permalink to Comment

32. Lu on February 26, 2014 1:08 PM writes...

Is that even legal?

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33. franklin on February 26, 2014 1:16 PM writes...

Sketchiness of the marketing and insider sales aside, I would be interested to hear the thoughts of this forum on the science of the HER-2/neu (E75) Vaccine.

e.g.
"Of 195 enrolled patients, 182 were evaluable: 106 (58.2%) in the vaccinated group and 76 (41.8%) in the control group. The 24-month landmark analysis DFS was 94.3% in the vaccinated group and 86.8% in the control group (P = .08). Importantly, because of trial design, 65% of patients received a lower than optimal vaccine dose. In subset analyses, patients who benefited most from vaccination (vaccinated group vs control group) had lymph node-positive (DFS, 90.2% vs 79.1%; P = .13), HER2 IHC 1+-2+ (DFS, 94.0% vs 79.4%; P = .04), or grade 1 or 2 (DFS, 98.4% vs 86.0%; P = .01) tumors and were optimally dosed (DFS, 97.3% vs 86.8%; P = .08). A booster program has been initiated; no patients receiving booster inoculations have recurred."

(http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3428069/)

Is the Phase III doomed to fail because the investigators identified the subset of patients w/ HER2 low-expressing tumors for whom the drug showed clinical benefit *after the fact* ?

Does the p value of the Disease Free Survival advantage (p =.04) for the treatment group take into account the fact that the analysis was "cherry picked" ? (I'm rusty on my biostats)

How likely is it that a similar statistically significant effect might be seen in the prospective Phase III trial?

Permalink to Comment

34. Hap on February 26, 2014 1:35 PM writes...

I'm also wondering how you get on the career path to astroturfing stocks. If no one has to disclose that they were paid to promote the stocks (the company Galen used pulled their notice after Feuerstein noticed), or that they paid someone to promote them, then paid stock promotion seems like a nearly endless source of funding for companies with no products and no consciences.

Maybe that's where new jobs will come from.

Permalink to Comment

35. biotechtoreador on February 26, 2014 1:39 PM writes...

And don't forget the Steve Kriegsman is on the BOD of GALE and CEO of CYTR. CYTR has done business in the past with Legend Securities (http://www.sec.gov/Archives/edgar/containers/fix071/799698/000079969809000006/ex10-38.htm).

Legend Securities (http://www.legendsecuritiesinc.com/) is also a well-known bucket shop.

Permalink to Comment

36. johnnyboy on February 26, 2014 1:53 PM writes...

@29 - It's not insider trading because it's not trading based on knowledge of actual events within the company that are unknown to the public. An executive who receives a response from the FDA and then buy or sells his own stock prior to making the response public - that is insider trading. An executive who hires a PR firm to froth up the company, then sells stock when the values goes up, is not insider trading because it's not dependent on actual events. I don't think that the hiring of a PR firm qualifies as an actual event. Even if it did, executives have ways around that, like setting up a share-buying or selling program with pre-determined dates.

Permalink to Comment

37. biotechtoreador on February 26, 2014 1:57 PM writes...

"I'm also wondering how you get on the career path to astroturfing stocks"

Just have a good smile and look slick in a suit of dress! Seriously, this http://www.corporateprofile.com/ is for real.

As long as promoters aren't directly trying to buy or sell stocks to clients (i.e. newsletters etc.) they're not beholden to FINRA regs on disclosure. To be clear, as in my comment above, even analysts subject to Reg. AC routinely will slap buy ratings on stocks just to obtain banking fees. A blatant disregard for federal law but common.

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38. Erebus on February 26, 2014 2:05 PM writes...

@30:
Mark Ahn is the CEO of Galena, Chang H. Ahn is the CEO of Rexahn. I don't think that they're related.

Permalink to Comment

39. Ari J on February 26, 2014 2:19 PM writes...

@35 - Correct, this is not insider trading. It does sound like a typical pump and dump scam, which can qualify as market manipulation, which the SEC does frown on a bit.

Such things can be reported to the SEC via http://www.sec.gov/complaint/tipscomplaint.shtml

Permalink to Comment

40. headshaker on February 26, 2014 2:25 PM writes...

Take a look at celceutix, claims that Danishefsky is on the SAB!!??, such a simple compound as a "specific" inhibitor, even when The FDA is alerted they get into Dana Farber!?. The saddest part is what the patients and their families have to go through. These companies do more than hurt investors.

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41. BuyersStrike! on February 26, 2014 2:26 PM writes...

@30,37

Just think of the synergies if Mark Ahn and Chang Ahn merged their companies!

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42. Anonymous on February 26, 2014 2:32 PM writes...

@38 headshaker,

That would not be the first time Cellceutix has fibbed. Check this out:

http://www.scribd.com/doc/204768693/MenonClaimsCheck

Do you know if they are lying about Danishefsky?

Permalink to Comment

43. Former Hana investor on February 26, 2014 4:55 PM writes...

Mark Anh is the former CEO of Hana Biosciences, which burned through a tremendous amount of money. Interestingly, someone accused Hana of being a "scam" back in 2004:

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=4174432

Permalink to Comment

44. biotechtoreador on February 26, 2014 5:05 PM writes...

My mistake in confusing Ahns.......

@39 Re "which the SEC does frown on a bit"

Good luck with that. I think I find the scumbags who make absurd profits off this kind of scam worse than the SEC that does nothing nothing about it.

Permalink to Comment

45. franklin on February 27, 2014 12:10 AM writes...

I'm going to try and phrase my last inquiry (@33) in a different and perhaps clearer way since it didn't elicit any responses.

based on the following result: HER2 IHC 1+-2+ (DFS, 94.0% vs 79.4%; P = .04), Galena biopharma received an SPA from the FDA to initiate a Phase III trial to investigate whether NeuVax will reduce breast cancer recurrence in patients with HER2 low-expressing tumors.

This Phase III is currently underway.

I am trying to understand why the consensus on this forum is that the whole endeavor must be a total sham, when this result (DFS, 94.0% vs 79.4%; P = .04) would seem to suggest at least the possibility of some merit.

If this result can be repeated in the Phase III, there would then seem to be the real possibility of a path to FDA approval, in which case the stock will trade at some multiple of its current price and the insider selling of recent weeks (Ahn says he sold only 20% of his equity stake) would then be re-cast as understandable and appropriate hedging/locking in profit as this stock was on the way up.

Why does everyone seem to be discounting the possibility that this effect could be replicated? Is it never the case that significance via post-hoc subset analysis might turn out to be a true effect rather than a spurious one, which the Phase III will validate?

really just trying to understand. thx.

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46. Scarodactyl on February 27, 2014 1:42 AM writes...

Galena? As in PbS? Perhaps appropriate, as people have been lead astray...

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47. Anonymous on February 27, 2014 2:12 AM writes...

@33, 45: "Is it never the case that significance via post-hoc subset analysis might turn out to be a true effect rather than a spurious one?"

Do you know of any examples where post-hoc analysis of phase II results was validated in Phase III? Does anyone? How likely is that, statistically?

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48. Anonymous BMS Researcher on February 27, 2014 7:28 AM writes...

The basic problem with a post-hoc hypothesis test is that we don't know how many hypotheses MIGHT have been found but didn't come up as "significant." If they tried 97 different hypotheses before hitting something potentially interesting with number 98, then in order to be truly significant at the 5% level the computed P-value for its significance would have to be less than about 0.0005. But we do not know how many different hypotheses *could* have been dredged up so we cannot know what if anything the calculated P-value means.

There is nothing wrong with data mining; it can be a great way to generate interesting hypotheses. But each such hypothesis must be tested with a different set of data, in which this hypothesis was a PRE-specified hypothesis. There is a huge literature on multiple comparisons, false discovery rate, etc., with which anybody doing statistics today had better become familiar.

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49. Anonymous BMS Researcher on February 27, 2014 7:45 AM writes...

To put it more simply, if I fire a shotgun at a barn door and then draw my target around the biggest cluster of bullet holes, that's gonna make my aim look more impressive than it truly was.

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50. headshaker on February 27, 2014 10:04 AM writes...

@42
There was an article where he was quoted as saying, "I don't even know them", it was quashed by their lawyer, not viewable on web anymore. A chemist that made analogs for them was never able to speak to him, Menon kept saying "Oh, I just got off the phone with him". Calls or emails to Danishefsky's office get no reply.
A basic S-alkyl isothiocyanate as a specific inhibitor of kinases with only millimolar activity and now this "guardian" stuff.

Permalink to Comment

51. Esteban on February 27, 2014 10:23 AM writes...

This appears to be a clear pump-and-dump scheme and the SEC could probably make a winnable case. Whether it elevates to the top of their to-do list is anybody's guess.

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52. Lyle Langley on February 27, 2014 10:31 AM writes...

@ 40, Headshaker...
"Take a look at celceutix, claims that Danishefsky is on the SAB!!??, such a simple compound as a "specific" inhibitor, even when The FDA is alerted they get into Dana Farber!?. The saddest part is what the patients and their families have to go through. These companies do more than hurt investors."

More notably than Danishefsky being on their SAB, check out their "business advisor" - Coach Jim Boeheim!?!?! Really, JB as a business advisor? Run, my friends, very fast and very far.

Permalink to Comment

53. headshaker on February 27, 2014 10:35 AM writes...

@42
Menon also claimed a doctorate in pharmacology from Harvard, when contacted, Harvard confirmed he did not, he now says he only did a post doc there, this fact has not been confirmed. When challenged on this fact the company changed the info in his bio.
They've jumped thru the hoops required to get into the clinic, but given the dimethyl fumarate story, guess we all need to learn more about how things work on the reg side of things. False claims from scientific staff seem to be inconsequential as long as the submission rules are followed???

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54. headshaker on February 27, 2014 10:43 AM writes...

Not saying any false claims made with regards to DMF, just another example of how one can get through the regs with just about anything by spending the money and following FDA rules.
Is this really what we spend so much time learning about chemistry for though, to be part of such exercises? Just thought this all might be a good discussion given the OP, maybe not, any and all criticisms are accepted.

Permalink to Comment

55. headshaker on February 27, 2014 11:13 AM writes...

BTW the OCI at the FDA were made aware of all these facts.

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56. bigredbruce on February 27, 2014 12:05 PM writes...

I commented somewhat tongue in cheek above about having done ok on my personal GALE trade. But in a more serious vein, I've speculated on a few stocks this past year in the GALE ilk and took my lumps when the stock tanked after a bad clinical result. I think you are clearly beter off if you try to follow more of a Buffet model of buying a stock with good fundamentals that you can invest in for years and earn steady solid returns over a long time period. Otherwise, you will fall sway to pump and dump schemes, or other "momemtum" events as no one can always time the market correctly (at least legally).

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57. franklin on February 27, 2014 1:45 PM writes...

@48 & 49: point appreciated - very well put.

But the question still remains, as @47 stated:
"(are there) any examples where post-hoc analysis of phase II results was validated in Phase III? How likely is that, statistically?"

This IMO is the heart of the question surrounding all the heated debate between Galena bulls and bears. Fortunes may be made or lost based on this one question, this one ultimately biostatistical question: can (DFS, 94.0% vs 79.4%; P = .04) be replicated in a prospective study?

From the tone and content of Derek's original post and from most of the comments here, it would seem to be an absolute foregone conclusion that the answer is an unequivocal NO, that Galena and its drug candidate NeuVax has no actual scientific merit, which would mean that we can predict with certainty that the Phase III will fail. If we are actually certain about this, then this would seem to be an example of the asymmetric information mentioned above (@21), since it could only be the unfortunate fools who do not possess this insight who are propping up the current valuation ($400 million market cap), and we could all pool our money, take out a substantial short position on this stock at its current price, and buy a medium-sized island after the Phase III results are released and the stock plummets.

So, I really hope to hear an answer to @47s question here. How certain are we?

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58. concerned on February 27, 2014 2:11 PM writes...

Another questionable problem is that their chief scientific advisor, who is also is an inventor of what is their pipeline, holds a substantial equity interest which is probably the majority of his net worth. How can he be unbiased?

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59. Anonymous on February 27, 2014 2:27 PM writes...

@57: For N data points there are N! ways of cherry-picking the data and finding the correlation you want, which makes it virtually certain that you will find it, and so the effective p value is 1.0. I.e., a completely worthless exercise. Hence, short the stock whenever you see that results are based on "post-hoc" data analysis, because most people will never appreciate just how meaningless the results are.

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60. Anonymous on February 27, 2014 2:31 PM writes...

Sorry I meant 2^N, not N!

Still, the results are meaningless.

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61. johnnyboy on February 27, 2014 3:29 PM writes...

@ 57 Franklin: "So, I really hope to hear an answer to @47s question here. How certain are we?"

This here is life sciences research; any life science researcher worth his salt is never absolutely certain of anything. Furthermore, we are looking at clinical research, in the most difficult field (oncology), within a commercial enterprise environment and all the information distortions that this entails - all this multiplies manifold the uncertainties. It also makes it possible for promoters to pick one minor positive aspect of a study and blow it out of proportion.

Since you're holding on to statistical significance (p=0.045, also known as skin o'the teeth) in the HER1+/2+ subgroup, it might help to look beyond percentages at the actual number of patients involved. We are talking about 4 out of 50 women with Neuvax having relapse, vs. 8 out of 34 controls. I don't know how familiar you are with clinical research; if you're not, I don't know how to convey how absolutely minuscule these numbers of patients are. It might help to think that if only one more woman with Neuvax had had relapse, you would have lost statistical significance - just one !

The other very large problem with the Ph2 trial is that, as pointed out by Feuerstein, Neuvax is a vaccine targeting HER. However, the statistically significant lower relapse was noted in the subgroup of women who had tumors that were HER 1+ or 2+ (ie. tumors considered to be either HER-negative, or HER-borderline). In HER 3+ tumors (i.e. HER-positive), there was no hint of an effect of treatment on relapse. How does a vaccine against a tumor component affect favorably only tumors that have little of that component ? It just doesn't add up. One more reason to consider that the stat. significant difference in the HER1/2+ subgroup is just a consequence of random chance on a tiny sample.
You seem like a sensible man, trying to find answers. I would really, really advise you that if you want to gamble on Galena stock, just don't do it with any money that you would regret losing.

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62. Anonymous on February 27, 2014 5:12 PM writes...

@61: Great analysis that pretty much sums it up: a bunch of greedy executives cherry-picking the data and distorting the stats to fatten their wallets, and a bunch of greedy but gullible investors taken in by it all.

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63. Anonymous on February 27, 2014 9:40 PM writes...

#61 FTW!

Very nicely stated.

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64. franklin on February 27, 2014 9:58 PM writes...

@61: Thank you - I really appreciate your insights and taking the time to explain the scientific reasoning behind the seeming consensus here.

I wish I could find an online source of actual rational discourse/debate about biotech stocks from a panel as informed as Derek and the participants on this blog.

Cheers!

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