Thanks for your reply, I respect your comments.
Regarding the committee meeting, they never even voted on the issue of approval of myotrophin, they did unanimously vote on agreement that the US trials showed significance, they voted "no" (don't know exact vote count) that the European trials showed significance, and voted "no" by a split count of 6-3 that the findings of the U.S. trials were enough to discount the European trials.
I'm not happy about the outcome of the meeting, but I don't see it so pure and simple that the meeting was a trashing of myotrophin and I think the full FDA will have a difficult time discounting a drug which has been voted significant in the treatment of such a horrific disease, politically and ethically( yeah I know FDA/ethical= oxymoron). And the FDA does not have to reverse any decision because the decision to approve myotrophin was not voted on.
RE: Question 1)Myotrophin is on an equivical basis following the meeting, both good and bad
Question 2)Agreed, Modafinil late 97-early98....myotrophin cost them money, if diasapproved then no more money spent on R&D, and is likely to be sold in Europe.
Question 3)To early to tell, options are still six months from expiration...if they thought this meeting was going to create finality with regards to myotrophin, they would have bought May calls. Until they get approval, this is a "hindsighted" question. I'm not necessarily a big fan in the option purchase, but the time to do this was before the meeting since a positive meeting would have made the purchase of calls afterwords much less valuable as the big gain is already realized.
Question 4)Yes on myotrophin and company has agreed the ALS market is limited. Whether other indications become developed may change this limited marketscope. Modafinil with large scope, besides narcolepsy- its initial usage- include attention deficit disorder ( an excellent alternative to Ritalin), and even jetlag, among others.
Question 5)Hard to tell as myotrophin costing the company up to this point, and committee did not necessarily vote against it, as stated above. |
