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Re: None

Thursday, 04/04/2019 11:46:11 AM

Thursday, April 04, 2019 11:46:11 AM

Post# of 3283
Ain’t talking nohow, noway about Fast Track possibility for pozi since they need to prove they are competent enough to get it but did see it granted to Ziopharm’s drug for their treatment of Recurrent Glioblastoma per their PR of April 1st. It’s interesting that they don’t have BTD status but received Fast Track. It seems you get many of the same benefits such as frequent communication w the FDA that you do w BTD. Per their PR

The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. A drug granted Fast Track Designation may be eligible for several benefits, including more frequent meetings and communications with the FDA and, if relevant criteria are met, the potential for Accelerated Approval, Priority Review or Rolling Review of a Biologics License Application (BLA).

https://seekingalpha.com/pr/17460804-ziopharm-oncology-announces-fda-fast-track-designation-ad-rts-hilminus-12-plus-veledimex

And that’s all I’m going to say about that...for now :)