TELESTA THERAPEUTICS INC T.TST

Advisory Committee Outcomes

[givmeabrake]

Here's an interesting report

Search this string in Google then open PDF

www.mckinsey.com/~/.../fda_advisory_committee_outcomes.ashx

[simouuun]

Out of 49 drugs recommended by Adcom, 43 were approved by FDA = 87.75%

[13PunterDog]

With only two adverse reactions to treatment as I recall , one with a urinary tract infection which anyone can get, they will send this through pretty quick too. JMHO. Safety is paramount and with BCG shortage / uncertain supply / toxicity = MCNA slam dunk. Advisory committee meets late November , 6-8 weeks after that expect approval, again JMHO. Buy as much as you can in $.40's , will be

[winx08]

@13PD, are the advisory commitee dates already known or is it a estimeated guess ? Will there be a special reporter (or how do they call it) who will write a report before de advisory comm ? Just followed your suggesting regarding buying :-) Reagrding AC´s .... Been on a bumpy ride in the past with CHTP. If i recall correctly, the first report was quite negative, AC vote 7-4 in favor and

[13PunterDog]

Winx: An estimated guess as it's halfway through our 6 month period. The FDA website has the Oncologic Advisory Committee meeting Nov 19-20. I think they meet 3-4 times a year ish , so the next meeting would be about late Jan - Feb '16 , cutting it close for Feb 27. The FDA usually follows it's recommendation , however , it is NOT binding. So don't anyone get their panties in a

[DryBones]

Punter,  whiile the FDA can ignore an Advisory Committee rejection, I have not seen it happen. The Advisory Committe are experts in their field. Only the heavy hitters, the big pharma, could mount a campaign to sidestep their recommendation. If the AdComm is positive, however, the FDA could still say no. I'm not worried about a no event too much, even though I think it is very

[RetailRube]

PD, might the Advisory Committee include any of the same people who participated in the panel of the FDA/AUA symposium on bladder cancer a couple of years ago?  After reading the transcript, I got a sense of how these people were thinking.

[13PunterDog]

RR: No chance? Maybe one.Here is link to Oncologic drugs advisory committee and rosters throughout this year. https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/ucm426351.htm They have rosters for July 9'15 and Jan7'15 meetings. About half attended both meetings .Here is how the committee is made up , we should just send Dr Morales

[Jasl]

Nice find givemeabrake very detailed report. Must have cost a few bucks. Looks like FDA human as well. Following the herd. Thanks for find.  Cheers JASL