TELESTA THERAPEUTICS INC T.TST

From 6 months down to 5 months approval time...

[Biofinder]

https://www.nytimes.com/2016/01/03/us/politics/fda-regulator-widowed-by-cancer-helps-speed-drug-approval.html?_r=0

Tic tic tic...

[Biofinder]

"Certainly there has been a change at the powerful agency. Since Ms. Pazdur learned she had ovarian cancer in 2012, approvals for drugs have been faster than at any time in the F.D.A.’s modern history. Although companies go through a yearslong discovery and testing process with new drugs before filing a formal application with the F.D.A., the average decision time on drugs by Dr. Pazdur’s

[HighteawithIntrepid]

32 or 1, hope your safe and sound and not stuck waiting for a cancelled flight.

[ragingbull1234]

Are you serious??   They move this slow and you are telling me that they've NEVER MOVED FASTER???    Hahahaha.  These people should be ashamed of themselves.    Yet they aren't.   And you aren't ashamed of them.    No wonder everything is turning to garbage.   You think less than mediocre is acceptable.    Sheep

[thathurt]

biofinder, thanks for the informative link...i had always thought of pazdur as a chemo bomber...interesting comments...and to link some other posts about Adcom's and approval, etc. Pazdur is correct in that IMO quality of drugs applying for approval is improving which results in higher Adcom approvals and FDA approvals...that makes TST and MCNA a risky bet, as i posted before T-VEC with good

[Biofinder]

I like Doug Loe's analysis: "If you believe a trial with these descriptive elements is insufficient for approval, you are not alone; 18 advisory panel members agree with you! However, the FDA and the American Urological Association disagreed in a mutually endorsed set of clinical protocol guidelines published in 2014 in the journal Urology, and this stands as our best evidence that

[thathurt]

bio, i like loe's analysis found him wimpy on price targets (binary event outcomes should have two target prices, one assuming positive outcome a second assuming negative outcome)...AdCom's are IMO a "confidence" game no more and no less..i assume panel members are honest but very risk adverse and all FDA BD's i've seen are "negative" (ie pointing to the risks

[Hatchchat]

my sandwich for lunch has a weird aftertaste lol. this whole story is a pure nightmare for shareholders, we're very close to the decision and our volume is lower than ever before. will we still see something like pre adcom? or will we be stuck here? your opinion?

[1wascallywabbit]

Will see rally, but only to 60's on significant lower volume -imho unless there is a major NR of course.

[Hatchchat]

yeah my guess too. why would anyone pump some significant money in here until the decision is here. my hopes are still up for a promising NR. IMO they owe it to their investors after the adcom debacle. maybe ipsen could also make a statement. but i guess i hope in vain.

[thathurt]

here is summin else to chew on...it is common folklore that no -$300M US marketcap company has ever been cancer drug approved by the FDA...as best i know this group has almost uniformly been unpartnered and are single drug companies who run very "skinny" programs reflecting cash constraints. who kept pushing programs that in big companies woulda been killed. sound a lot like TST

[thathurt]

chat, flip a coin (and hope heads has a little more weight)..IMO the boobsy twins hit their Murphy moment at adcom, but the two consultants were really grade A excellent (as good quite frankly as i have seen) they were expert, knowledgeable, clear, etc. but that got lost on the butchery of TST uneffort (remember Adcom is a voting booth of risk averse and "ah um" "can we get back to

[givmeabrake]

Agreed Hurt, In my opinion as a regular small business person, even i know to prepare for worst case scenario and show up to game changing meeting with appropriate weaponry.    Their team appeared weak and they blew it.    Make-up should have been as so...   1- lead spokesperson/facilitator - 'The Communicator' - skills of a litigator.  2

[blartar]

offer them more  " CHEAPER OPTIONS "  just before they meet and I guarantee they will get it right this time.    JMHO & GL2AL