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Re: DewDiligence post# 585

Wednesday, 09/10/2014 11:17:08 AM

Wednesday, September 10, 2014 11:17:08 AM

Post# of 2961
The race to get a drug to approval is very important in the HCV space.

I have felt that this was a little slow progressing from 2a to 2b.

I have wondered if it had to do with;

1 ) the hammering out of final agreement on the intrinsic value of 450 into the royalties.

2) the ability of ENTA to co-fund the trial, to be able to share expenses. (or how could they know whether they could participate (w/493) until they knew the exact share (w/450) they would get?)
It would also seem to me that they would also have to understand the size and scope of trial design for this. ( for example, are there 6, 8, 12 or 24 week arms? Scope of drug interaction trials, etc)
From what Luly has said the FDA has made the approval process more expeditious compared to the past.

3) ....which may have also played into a stalling of the phase 2b trial.....pure speculation. Or tweaking the 493/530 agreement.

Even the word stalling may not be a good choice of words. But just recently 2017-18 approval is a time frame I have not heard before until recently; prior it was 2017.

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