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February 26, 2002
A Certain Tension in the Air
Well, today is Imclone day at the FDA (see Jan 31 and Feb. 6 postings.) All parties will be meeting to decide what the path forward is: reworking the existing data, supplementing it with whatever else the companies can dredge up, or new clinical trials.
Analysts have raised the possibility of using some clinical data from Merck KgaA (German Merck, not the US company.) They're the licensees in Europe. But most of their data is for head and neck cancer, which won't cut it for Imclone's colon cancer application. Merck has apparently done a couple of small trials in colorectal patients, but most of their data for that indication's European filing was supposed to come from Imclone. There might not be enough new data to salvage things, considering how negative the FDA was the first time around.
If Imclone gets to reapply without new data, I'd chalk that up to the work of experienced regulatory-affairs people from BMS. I assume they've brought in everyone they can find. Of course, that brings up the question of where those folks were for the first filing, doesn't it?
I wouldn't be surprised if it turns out to be new trials, which is of course what the companies want to avoid. If that happens, look for more now-we're-really-mad statements from BMS, and another round of nasty press releases.
The pity of all this is that Erbitux very likely works. That puts pressure on for approval. You already see comments about the mean ol' FDA hasseling this small company with their wonder drug, but that's missing the point. If you want to get mad at someone, get mad at Imclone for doing the absolute minimum they thought they could get away with. And get mad at BMS: I still think they should have caught this before it went to the FDA at all.
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