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TELESTA THERAPEUTICS INC T.TST

"Telesta Therapeutics Inc is a biopharmaceutical company. The Company is engaged in the research, development, manufacturing and commercialization of human health products and technologies."


TSX:TST - Post by User

Post by RetailRubeon Dec 24, 2015 1:23pm
364 Views
Post# 24412010

AdComm Transcript

AdComm TranscriptI finished reading the AdComm transcript.  I also read the FDA briefing document published 2 days in advance, and the Telesta presentation to the AdCom.  I thought the Telesta presenters were highly professional and the non-employee presenters were impressive and compelling.  I was glad Monique handled the meeting because of the level of detail and history needed for some of the questions asked.  I thought we got our points across on all the issues, at least to the FDA, even if some of the panel members were dismissive.  Although Berendt did not speak during the meeting, I have no evidence that he did not attend.  (Some posters on Stockhouse have said he wasn't there.)  The final vote was difficult because the voting question combined CIS and Papillary.  That was the FDA's doing.  These two diseases do not sit comfortably together in any discussion.  If the FDA turns this down outright, then the FDA will have to wait more than 10 years for bigger/better data with full followup and full biomarker/genome analysis.  I assume that is also a consideration for the FDA, even though it was never mentioned in the AdCom discussion.
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