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There is an outside chance that additional data would be requested. Also possible, an approval with mandated collection of additional data (a Phase IV trial). Still, I agree that if full disapproval was coming, the April 9 meeting would have taken place as scheduled. The advisory committee would have recommended disapproval and the FDA would have followed. I'm optimistic. Market does not seem to know what is going to happen. Taking the stock down 3 points was certainly not the equivalent of what we'd see if there was a disapproval. Also, this is not a one drug company. Chiron will manufacture Myotrophin and there are limited partners who underwrote the development of the drug. These folks need to be paid. How much is left for Cephalon isn't all that clear. And, while ALS is a devastating disease for any individual, the total market is not that great. Some think that Provigil is the key drug. It is used for narcolepsy (a substantially larger market than ALS), with possible off-label use for attention deficit disorder. Phase III trials in US, Canada and Europe produced statistically significant findings, with possible approval later in 1998. If both these drugs were to be approved in 1998, Cephalon would really take off. |
