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Biotech / Medical : Magainin Pharm (MAGN) -- Ignore unavailable to you. Want to Upgrade?


To: Bob Swift who wrote (192)6/26/1999 6:17:00 PM
From: Mike McFarland  Read Replies (1) | Respond to of 233
 
Just a quick look on the recap site
shows that SmithKline was into that
deal for 32.5M--I suppose a person could
sort through all the quarterly reports and
see just what milestones were met, and how
much was spent on the trial... Don't know
how long that trial took, impetigo--I was
not following magn for a couple years. But
it wont take long for an answer to pop up,
either here or on the Yahoo thread.

If pex fails, expect the burn rate to
come down quite a bit, I cant see them
launching a whole new trial. And I don't
see how the FDA is going to ask for "better
control". Maybe I am dense, but if the stuff
is as good as oral antibiotics, I think you
have to add it to the arsenal. Everything
that I heard on the vcall sounded positive,
hope I have not deluded myself. Have you
listened to the vcall tape?



To: Bob Swift who wrote (192)6/26/1999 6:46:00 PM
From: Shlepper  Read Replies (2) | Respond to 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.