<<I refer to Puck on the fast-track approval likelihood.>>
Thanks. :-0
Well, for one thing, on the Puerto Rico conference call mucho skepticism was expressed by analysts. But simply put, here's my take.
To get on fast track (where the FDA reviews and acts on an NDA within six months of submission date) you've got to have a so-called "priority" drug. Those are the ones which seem to have an advance over available options. Biotime may fit this bill. However, wait a sec....
In normal review the FDA reviews and acts on NDAs for "standard" drugs, i.e. those which, based on the submitted evidence, have therapeutic qualities like those of an already marketed drug.
So now, based on submitted evidence (we're talking Phase III data primarily), it looks like Hextend comes up as a "standard" drug- remember the endpoints were to show equivalence, not superiority.
Pretty simple argument, I'd say.
As always, I could be wrong. Remember I'm not even close to being an expert, and the info I have is merely gleaned from past experience and a perusal of the FDA web site (which is quite good, BTW).
Anaxagoras/Puck |
