>>10-15% of the time fda approves<<
Mike, we should clarify that the statement here was that 10-15% of the time the full FDA overrules the position taken by the Advisory Committee.
Zasloff certainly put his credibility on the line, didn't he? He stated unequivocably that of the FDA's three options, only one (approval of Locilex) would make any sense. The drug has a good safety profile, it appears to appears to work, and the only way to satisfy the Advisory Committee's desire to see placebo controlled trial results would be too inhumane. To review, the three options are:
1. Another study involving placebo
2. Approve, and continue to work
3. Drop the matter entirely
Option 1 is unthinkable. The prognosis of diabetic foot ulcers, when treated with placebo, is awful. The FDA cannot asks patients to volunteer to have their diabetic foot ulcers treated with placebo and then face likely amputation!
Option 3 is just as unthinkable. This is a very nasty malady. The FDA has expressed interest in Locilex. It is an effective treatment for a critical unmet need.
Option 2 is the only one that makes any sense.
I took a starter position today at $1-3/4. Hoping for some excitement to come out of this weekend's presentation to the American Diabetes Association. The real test will come next month: by July 24th.
If the FDA turns Locilex down, it won't be the end of the world for MAGN. It is not a one-drug company. Squalamine, in particular, looks very promising.
Marc
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