TELESTA THERAPEUTICS INC T.TST

Anyone have guess on where we go from here?

[SamuelSamuelSam]

Anyone have guess on where we go from here?

[PharmaGuy42]

imo: We're pretty much done until Febrary. Simple as that.

[Gary1959]

3 months will go fast. We will get it done in march

[Kveinot]

Does anyone have stats on what percentage fail the advisory committee yet still obtain fda approval?

[DamnYankees]

I suppose that Telesta will have to engage in some discussion with the FDA to see whether MCNA is approvable under its current submission platform. Somehow Valstar got approved after an Adcomm rejection and few would concur that it is a more substantive treatment than MCNA. Its not over yet but this will hurt.

[Frogger2]

I can't remember where exactly but I did read that Berendt does have a back up plan. I hope he unveils this sooner rather than later. I was able to listen today but did read the uopdates, it seemed like the committee for the most part were looking for reasons not approve rather than what it did do for the patients involved in the study and the good it could do.  There was also a comment

[ROIHunter]

Company has $40m in cash.  While 2/3 of Advisory Comm said no, 1/3 said yes and were quite enthusiastic.  Will be very difficult to reject the drug outright esp on fast track.  If they do then the drug is likely dead in the water and never to be developed.  Even the negative opinions almost to a person wanted to approve the drug and or thought it would do little or no harm

[SteveMcM]

Found it interesting that 4 of 6 bladder cancer doctors voted yes.