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Re: sentiment_stocks post# 65664

Monday, 06/27/2016 11:39:55 PM

Monday, June 27, 2016 11:39:55 PM

Post# of 689408

And so with regards to AA or priority reviews... I've not found one example of a company that's PR'd they are filing for either such designation. They may hint they intend to... as did Celldex on the Rindo P2... but they'll NEVER PR they filed for it. In fact, you'll find no such example of a public PR of that even for Celldex.


You do not file for AA or priority review.

You file the BLA.

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

One might "hint", or even clearly predict, that a submitted BLA will take an AA or priority review path. For AA they might even have discussions with the FDA.

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

EDIT: It might be the case that a SPA might incorporate an AA request. But SPAs usually are PR'd.
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