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TELESTA THERAPEUTICS INC T.TST

Healthcare Biotechnology
"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

TELESTA THERAPEUTICS INC > I heard that the FDA wanted 2 more P3 trials...
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Comment by scroll4factson Aug 30, 2016 9:01pm
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Post# 25193551

RE:I heard that the FDA wanted 2 more P3 trials...

RE:I heard that the FDA wanted 2 more P3 trials...Why such a giant leap between the FDA written guidance received just over 2 years ago and this monumental task?  It seems obvious to me that MCNA is relatively safe and efficient for those who are unable or failed BCG.  There is a large and unmet medical need and I understand that many are left without much alternative.  Having a good safety profile, I don't understand why MCNA has not been approved for compassionate use when nothing else is available besides a risky and unwanted cystectomy.

https://www.stockhouse.com/news/newswire/2014/07/18/bioniche-life-sciences-(t-bnc)-jumps-65-on-intention-to-file-for-us-marketing-approval-of
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