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Biotech / Medical : Magainin Pharm (MAGN)
MAGN 9.090+6.2%Oct 31 9:30 AM EST
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To: Bob Swift who wrote (192)6/26/1999 6:46:00 PM
From: Shlepper  Read Replies (2) of 233
 
Hi Bob,

I know I've seen you on other threads. Welcome here.

Your questions are good.
With over 1000 involved in the study - by far the largest ever in trials involving diabetic foot ulcers, safety and efficacy of Locilex has not been disputed. The issue must still be resolved by the FDA regarding the use of placebos rather than oral antibiotics as the control. The FDA designed the study with no placebo control, and the FDA advisory panel rejected this approach. The cost for conducting the trials was considerable - though softened by SKB milestone payments. There's no way of telling how big a study the FDA would require for placebo controls should they take that route. If you look at the SKB homepage, they have high hopes for Locilex - and may continue to support the effort.

Having said all of this, I cannot fathom the FDA requiring additional review with placebo controls. They felt it was unethical when the study was first designed, and it would be hard to justify reversing that decision. The advisory panel clearly erred.

I'm not unhappy with the current price of the stock. I'll continue buying at these low prices. The stock has already factored in the advisory panel decision and with an FDA approval, the stock should jump back up to the 5 to 9 level. In the meantime, the squalamine and asthma genomes should continue to boost the stock.

I believe that there is sufficient resources for the company to progress on all fronts, though if Locilex is rejected or requires additional high cost testing, then Magainin will need to do more creative partnering and licensing to maintain their operation.
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