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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

Comment by Str8Shooter88on Apr 13, 2016 4:09pm
146 Views
Post# 24763305

RE:Please read Telesta Therapeutics Receives Complete Response

RE:Please read Telesta Therapeutics Receives Complete Response
hanelhag wrote: MONTREAL, Feb. 2, 2016 /PRNewswire/ - Telesta Therapeutics Inc. (TSX:TST) (PNK:BNHLF) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter to Telesta's Biologics License Application (BLA) for MCNA1. In this letter, the FDA communicated that an additional Phase 3 clinical trial for MCNA would be necessary to adequately establish MCNA's efficacy and safety. The FDA also encouraged Telesta to meet with them to discuss further clinical development of MCNA. Read more at https://www.stockhouse.com/news/press-releases/2016/02/02/telesta-therapeutics-receives-complete-response-letter-from-fda#OtusfQV5LGTeu66G.99


Yes, so in other words, the FDA wants more development done and/or another Phase 3 clinical trial before anything goes to market. End of friggin story. So this is what they are discussing and will be reporting on over the weekend...price is where it should be at the moment as things are not going to market until one or both of those things are accomplished. 

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