TELESTA THERAPEUTICS INC T.TST

The 88/12 rule

[runningonempty]

Its been a week since the ADCOM meeting when we all hoped for a better result. Unfortunately that never happended as TST management squandered there opportunity for a positive outcome. 
Since then they have been silent except for the standard we are disappointed with the outcome and have answered e mails the same way.  We will continue to work with the FDA and ADCOM is not the final decision. What they forgot to say was we screwed up.
I doubt we will hear from TST management again prior to February decision unless they receive a refusal from FDA before to the 27th.
There has been lots of good information posted here as to what TST managment should have done or can do, sadly it means nothing in the real world. My gut tells me we will not be approved, the stock price is finished and we will lose our promising investment due to arrogance, stupidity and not understanding your opponent.
The truth of the matter is a positive ADCOM results in an 88% favorable approval by FDA, a negative ADCOM has a slim to none change of being approved. Thats where we are grasping at straws hoping to survive with little help, input or promise from TST management.
I hope I am wrong, but I just don't see it.

[HankTheHippie]

sadly I would have to agree with your opinion on the unlikely positive FDA approval. But I still ask, "why would the FDA fast track"?, Even if the result is a no, do we not have other plays (royalty deal etc)?

[ragingbull1327]

The answer to why the FDA fast-tracked MCNA is because all of the other companies who have tried to come up with something EFFECTIVE for these people in need for the past 18 years have been firing blanks.   Even the last one they DID APPROVE is essentially garbage, it was just the BEST available at the time.   Not anymore.....obviously 

[thathurt]

running, re. 88% rule and my perspective (which i've provided before): a) it is a reflection of the way it should be, most companies who get to AdCom typically have sufficiently supportive substantial data, etc. to support a yes vote; i offer AMGeN (???) recent T-Vec AdCom...they had a ton of clinical data generally but weakly supportive of effecicacy that didn't actually extend life, but

[Tson99]

You said, c) TST data package was "slim and weak" quite frankly and no one should deny this... safety was great but efficicacy support required certain beliefs from members ( i had a personal prediction of like 16 yes and 6 no) as data was not unequivacal in this matter (imo most damaging was that durability of response was questioned as to whether it was MCNA or BCG effect) Weren'

[DamnYankees]

Tson, To be as frank as possible, many of the No votes had strong opinions about BCG to the extent that they sounded worried that MCNA would supplant it as a frontline treatment in some circumstances. That was not the sprit of the question, under the broadest of interpretations. It was debating the merits of your wallpaper with your plumber. I think that the FDA will recognize some of the Adcomms

[givmeabrake]

EXACTLY!!! "Weren't all of the patients in the trial deemed non-responsive to BCG????? How can you or the panel then question wheter it was MCNA or BCG that was providing the benefit? The whole point of the trial and the BLA is to help people that are non-responsive to BCG."

[thathurt]

tson, again another silly attack on this board when you posted this: <

[ragingbull1327]

Seriously? This is OVER-analysis. The FDA ACCEPTED the "slim data", because the mountain of data they do have, is from a 17 year old treatment that sucks. How is having LOTS OF DATA better than something that flat-out works?l better?