TELESTA THERAPEUTICS INC T.TST

FDA Comment:

[tater1]

FDA Comment: It should be noted that all subjects from Studies 301 and 303 received prior treatment with BCG, and these studies did not enroll any BCG-nave subjects. Thus, it is unclear if the responses to MCNA treatment observed in these trials required prior treatment with BCG to prime the MCNA response. 

OK, good enough, but since we were  attempting approval for a second line treatment, the patients will always be treated with BCG before MCNA. So why does it matter?

[SteveMcM]

THe FDA is concerned with MCNA's efficacy, independent of prior treatment. Is seems from their point, they wonder if the prior treatment with BCG is positively affecting the MCNA mechanism of action within the second line patient pool. This is an important question, becuase if MCNA was given off label to BCG naive populations, then the MCNA efficacy could suffer as a result.

[tater1]

Considering the panelists views it would seem unlikely that anyone would dare use anything but BCG firstline. Is the FDA responsible for off label use if they approved MCNA for limited therapy? Judged by the oncologist comments regarding other chemotherapy used without approval it seems to be a free for all as far as therapy of choice.

[DamnYankees]

Like many of the questions that arose, this question of BCG priming the MCNA mechanism sent the panel spinning off into another tangent about the relative merits of BCG. Again, again and again they lost sight that the question was about 2nd line refractory, not a treatment that would usurp BCG as the "gold standard". having an FDA appointed moderator might have helped keep things in line

[ragingbull1327]

I'm wondering what information from AdCom will benefit the FDA?   I'm still trying to understand who exactly the meeting was for, and the only thing that makes ANY kind of twisted sense is the stock trader.    I don't think the FDA was ready for the volume of audience, as after about 30 seconds, regardless of what conferencing software I used, the audio would start to

[DryBones]

It probably wouldnit of mattered if our VP in charge could have answered the question.