TELESTA THERAPEUTICS INC T.TST

Everyone should just take a step back and calm down.

[LittleLadyPhD]

Everyone should just take a deep breath. Yesterday was a big disappointment but most of us who have been following the MCNA story closely knew that Telesta staff had not done a good job presenting their data at the Ad Comm and we knew FDA approval was a 50/50 chance. We were hoping the global BCG shortage would play into the FDA decision and that their earlier involvement in the MCNA study design meant they would overlook the study's shortcomings. Unfortunately, this didn't happen. But MCNA still offers an excellent alternative for this particular group of bladder cancer patients and may even be of use in a wider group of patients in the long run especially if BCG continues in short supply. This is a good take on what happened yesterday and what the future might look like: https://www.stockhouse.com/news/newswire/2016/02/02/telesta-therapeutics-t-tst-slammed-down-76-after-fda-delay

[thathurt]

i agree and on AdCom fiasco i would replace current leadership, stunning failure of leadership really.. ..other issue is failure of TST leadership to get moving on EU approval.. MCNA is no help to BCG shortage unless it is approved for use. MCNA is not help to patients in need unless it is approved for use.. ..PIII redo in US per FDA will cause 4-5 year delay...

[DamnYankees]

Hurt, Is there any recourse with the FDA, maybe in the form of an appeals process seeking a parallel trial, expedited trial or lesser/limited  indication? I am not well versed in the apparent "all or nothing" nature of this BLA. There was significant discussion around the "surgery unable and unwilling". Are those people essentially SOL with no option available? 

[thathurt]

dam, here is what i believe/know: a) companies receiving CRL's rarely if ever give a full account of the failings (FDA did a study confirming this as they are concerned about "truth") b) FDA had a range of options available if uncertain (like asking for more data) but i suspect had determined it had enough data c) re. 2nd trial, that is pretty much FDA SoP and as MCNA failed in

[Frogger2]

It was a huge disappointment and I agree with your comments. I am hoping there are all hands on deck meetings happening now to establish the go forward strategy and get the next step moving. I understand the lack of PR communication between Adcom and FDA decision but it is now critical to tell the world the action plan as soon as possible. We will settle in at some level over the coming weeks , a

[thathurt]

frogger the contingency plans should have already been prepared and now it should only be execution.. for instance, all plant staff should be immediately laid off and with any business development teams, etc. IMO TST has burnt through a lot of its cash horde..$0.30 is IMO a pipe dream, it was that before CRL as still a chance of approval now there is none