Rudy, you seem to be one factual person in a sea of trash talkers.
CEPH is holding strong today as wise people have seen right through the Barron's article. It definitely isn't over, yet.
One important item regarding lasts week's meeting is that the final outcome was not a thumb's down, In fact the advisory board was never even asked to vote on the crucial question, "Should myotrophin be approved for marketing?" The FDA doesn't even have to "overturn" the board's decision to go on and approve, which is probably why they never asked it in the first place.
Specifically, the advisory board voted on three questions. The first was whether or not Myotrophin showed significance in the U.S. trial. The answer was a unanimous YES. The second question was whether or not the European trial showed significance, The answer was NO. The third question was do they think the first trial was strong enough to discount the second?
The answer was, again, NO (6-3). And I believe the no votes come from the rigid naysayers who can look at the ALS community and say "sorry, but we need another 3 years and another phase III study to confirm the U.S. study, sorry if you'll be dead by then."
They agreed unananimously that the U.S. trial showed significance, and they never rejected myotrophin, which is what all the next day headline's read.
If they give the consideration of a drug that has shown significance for a terrible disease, in the same light as they gave to approve Rilutek, we will have approval of myotrophin. The following is from a non trademarked press release following the approval of Rilutek:
From a news release of Dec.1995 when the FDA granted approval of Rilutek.....
<<Commenting on the approval, Secretary of Health and Human
Services Donna E. Shalala noted that when tested in two placebo-
controlled studies on more than 1,000 patients, riluzole prolonged
survival on average by about three months.
"This is a modest effect, but before riluzole there was no
therapy for ALS at all," the Secretary said. "Today's approval is
an important milestone in the decades-long search for treatment for
this devastating disease.">>
Myotrophin is a better drug than Rilutek by far if you have to choose one to treat ALS, the two combination might even be better since they do different things and work in different ways to help the ALS patient.
Myotrophin will be approved, the smart know it, and the market reflects this knowledge. Ceph may drift a bit....but there will be no crash and burn.
P.S. Why waste your time reading, let alone trying to respond to, harkenman? It's useless and he's worthless. |
