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
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