NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

You do not file for AA or priority review.

You file the BLA. - exwannabe

Okay.. right... a company requests AA or a priority review.

Celldex never filed the BLA, so could not PR that they did.

Right... they "requested" AA. And did not PR it.

But there is NEVER a submission of a "request" for AA or priority review. So of course you will find no PRs on such. - exwannabe

I'm not sure what you mean by this... are you suggesting there is no submitted paperwork involved when they request AA or a Priority Review? I can't imagine they just ask for either one verbally.

I would think there has to be some sort of "submission" of this "request". And you could PR it if you wanted. It just would be pretty stupid to do so... in the event you are refused... like Celldex was.

Sponsors may request priority review designation when they submit an original BLA, NDA, or efficacy supplement. The Agency does not anticipate that priority review designation requests will be made after the filing of a BLA, NDA, or efficacy supplement. - page 33 http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf