« Pfizer's Future: Biotech Followups |
| The Scent of Food Is Enough? »
April 29, 2010
Treatment INDs - For Any Generex Fans Out There
Adam Feuerstein schools the Generex folks on what a "Treatment IND" really means, quoting chapter and verse from the FDA. The company's fans have made much of that designation for its flagship buccal insulin product. As has the company's CEO - but that link shows her making statements at investor conferences which are, on the face of them, in flat contradiction to the FDA's own understanding of such matters.
The article's worth reading even if you don't give two hoots about Generex, since it'll give you an understanding of what it means (and doesn't mean) when a company has a product designated for "compassionate use". It can also give you an understanding of what it means when a company misrepresents that status, but I think a lot of people here already know what that must mean. . .
+ TrackBacks (0) | Category: Business and Markets | Diabetes and Obesity | Regulatory Affairs
POST A COMMENT
- RELATED ENTRIES
- Some New Reviews
- A Structure From the Molecular Sponge
- Biggest US Cities for Biopharma Funding, Versus Whole Continents.
- We Are Pleased To Publish Your Senseless Ravings
- Traveling Interruption
- More Good PD-1 News in Cancer
- Novartis's Stealthy Headcount Reductions
- Sydney Brenner on the State of Science