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Re: arvitar post# 122538

Friday, 06/24/2016 12:19:54 PM

Friday, June 24, 2016 12:19:54 PM

Post# of 146213
Clearly it was not fraud. It was an aggressive timeline, obviously overly optimistic in retrospect. It was an estimate and a goal, not a "promise" as you have stated in the past. Nobody can predict the future.

Continuing to repeat "fraud" doesn't make it so.
Continuing to rehash the same arguments daily is tiresome.

What is the absolute shortest time, in your opinion, that a drug could be FDA approved? What drug had such a short development time?

We'll see how fast FDA can move, for "emergency" situations, for instance when it comes to INO's Zika vaccine - if it has good results. What about for Ebola? I bet the FDA would approve something quickly for that if we had another epidemic. Sometimes drugs with outstanding results could be approved after Phase II. These are exceptions to the norm, of course. Some of NNVC's drugs could meet some of these exceptions, but it's hard to predict.

As an aside (doesn't apply to NNVC), Japan has new rules to allow payment for regenerative medicine / cellular therapies that show safety and "probable" benefit. That will allow for very short "conditional" approval times there with reimbursement for the drugs while they are studied further.
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