TELESTA THERAPEUTICS INC T.TST

Adcomm green light odds

[crocky]

I've been sifting through the details for some time and became interested in the report by Ford on Seeking Alpha. While he does promote the 88% success rate of FDA approval following the adcomm recommendation, he doesn't address the odds of a green light from the adcomm meeting. What do you feel the odds are of adcomm approval based on the strength of the Phase III trial - part (a) - and the absence of a Phase III part (b) trial. Thanks.

[PharmaGuy42]

Phase 3B are not, (and have never been) a prerequisite to getting a green light. 90% of cases are done with Phase 1, Phase 2A/2B. and Phase 3. In my experience, delays usually include repeated Phase 2 studies dealing with Lot consistency, comparator studies and non-inferiority. Also, oncology drugs, which are cytotoxic by nature are assessed differently than most small molecule drugs. This drug

[crocky]

Thanks PG. I think that Telesta managment felt the odds were pretty high as well. The guidance provided to them by the agencies does not appear to be misleading.