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Bullboard - Stock Discussion Forum 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 Discussion

TELESTA THERAPEUTICS INC > Please read Telesta Therapeutics Receives Complete Response
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Post by hanelhag on Apr 13, 2016 2:20pm

Please read Telesta Therapeutics Receives Complete Response

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
Comment by Str8Shooter88 on Apr 13, 2016 4:09pm
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. 
Comment by zahmed70 on Apr 13, 2016 4:15pm
Thats exactly Why they are meeting  .. Type A meeting is for products are are in limbo ... or stalled ... so that they can proceed  .....
Comment by DryBones on Apr 13, 2016 4:34pm
The complete response letter is very old news.  It was a complete rejection letter with a few kind words thrown in.  The letter said quit wasting FDA time with inadequate clinical studies, come back when you know what you are doing. This is why the stock is trading for less than cash.  The cash will be gobbled up on any meaningful clinical testing.  Then they will need more ...more  
Comment by LYNXSECRET on Apr 13, 2016 4:51pm
SAME HAPPENED TO BIONICHE THEY HOOK AND BATE YOU THEN REEL YOU IN AND THEN FEED YOU AS BATE TO THE ABISSSSSSS OF LOSSES 
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