TELESTA THERAPEUTICS INC T.TST

Anybody read up on Adcomm

[DamnYankees]

Wondering whether anybody else has investigated Adcomm & FDA results for second line oncology submissions? The closest anyone has come to touching on it was Mr. Ford. I mentioned last evening that the criteria and threshold  for second line approval would seem to be different from frontline. Efficacy, safety, urologist support, immediate need and Insurance clearance. This might be the quietest almost layup in the history of biotech. The biggest unknown for me is what side of the table  Endo's representative will be sitting on

[greenbacks]

Did you check out my post last night and the linked article?  Here is the first thing of note in it. I think that this bodes well for our chances.  I have been a little nervous about not meeting the primary endpoint and the single trial etc... this article has lowered my nervousness by half. :) Key Article Points: 1. Accelerated approval by line of therapy We found a noticeable

[DamnYankees]

I did thanks. Clear and concise. There is also some data available that speaks to the differences in the review and approval process for 2nd vs first line treatments. To your concern, I think that the primary end point in that trial has since been deemed irrelevant as it was, in hindsight, so far beyond what the FDA considered a noteworthy result. Why missing the endpoints is continually

[greenbacks]

Nice to see we are on the same page!

[Frogger2]

Nice posts Yank and Green! I did not realize Endo would have Rep on the committee? It seems odd in two ways, they are a stakeholder although small with Telesta and they stand to lose market share if appoved. Strange

[DamnYankees]

I was half kidding with my ENDO comment. Having said that they are the only organization I am aware of that would have any reason to oppose this. Yet their royalty stream and territorial rights for MCNA would probably generate a better rev number than Valstar. It is an unusual position to be in. Still a strong possibility that they partner with and or but Telesta.