Replies to post #25441 on Cel Sci Corporation (CVM)

[lightrock]

Up to a couple years

And yes, the kind of study this is, should be either totally ++ or totally flop and it should be immediately apparent.

[Spideyboy]

Seems you are new to the Drug Development space. 6 months for review is not a long time, in fact that is considered lightning fast.

Normal time would be 10-13 months.

Fast-track would be about 8-10 months

Accelerated Approval would be 6 months, but that is usually based on surrogate biomarkers predictive of the disease from a trial usually before the Phase III trial is completed, and we would not be using surrogate bioarkers in this study.

Additionally, for Fast-Track a company should usually get the designation before the trial, so this isn't happening for CVM on this trial.

If that data is truly outstanding, then it may be possible that the FDA may move things faster but that would be very unusual. It may be possible upon the data that CVM may request for Fast-Track as the request must start from the company side. But that we will have to see.

MK does have ODD but that effects the size of trial and discussion priorities with the FDA not review timelines.

Based on what we know now, after data we are most likely looking at about 10 months for review.

IMO- very unlikely CVM gets sold after data.


http://www.pharmexec.com/how-fast-are-fda-fast-lanes