TELESTA THERAPEUTICS INC T.TST

Decision time frame....

[txbioinv]

Don't be surprised if we get a decision tomorrow, if not, by end of this week. Lately, FDA has been issuing decisions one month early, irregardless type of BLA application type/status; plus that's their unofficial goal as the FDA leadership has stated, especially oncology drugs. GL longtimers. ........

[Biofinder]

Yep.

[Mackinnon80]

Could you please give us a few example of original BLA (with priority review) that were approved one month before the PDUFA date...in the last year or so ? On the FDA list I have, these drugs (approved earlier) had all received either the "breakthrough designation therapy" or the "fast track designation"...unlike MCNA. M80

[Hatchchat]

here an article mate, but there's not example in it. i found it to be hard to find something specific, but i guess it's because generally the FDA maybe announces it only few days earlier, not months. so it's not worth a real news to say "it was too early!" but rather to just say a decision has been made. so with telesta we're talking about some days now too, not 2 months

[txbioinv]

m80, appreciate the valid question. I'm specifically going off comments made from both from the current 'acting' FDA Commissioner who is filling in for the resigned Hamburg (March 2015) and the Oncology boss (whose wife passed away from cancer). I reviewed last quarterly fda approvals for all drugs, and surprisingly a number of them, decisions were early. No, I didn't specifically