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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 > I think they got Priority Review
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Post by RetailRube on Aug 28, 2015 12:03pm

I think they got Priority Review

They must have heard something from the FDA, to justify a halt.  They would have had to wait until the end of today to say "We didn't hear by Day 60 and so we are now only elegible for Standard Review."  Therefore they must have gotten Priority Review.  And you don't get Priority Review if you get an RTF.  Therefore, I think we are on a runway that ends in February 2016.  But as always, I could be wrong.
Comment by DryBones on Aug 28, 2015 12:10pm
we can speculate, but it is also possible it was rejected, in which case we wont hear until after the market closes.  GLTA
Comment by RetailRube on Aug 28, 2015 12:13pm
Killjoy.  That's an RTF.  Why reject on Day 60?  Why not Day 14 when they schedule the meeting with the FDA Division Director, per their procedure manual?
Comment by loveshackdave on Aug 28, 2015 12:17pm
Why would they issue a halt if they were going to wait until market close?
Comment by RetailRube on Aug 28, 2015 12:21pm
In case there is a leak, such as in the Press Release organization, or maybe their e-mail system has been hacked and an outsider has already read their e-mail.  Officially or Unofficially.
Comment by princeofcut on Aug 28, 2015 12:42pm
ROTFLMAO...so again we have the TST bagholder cabel rep jerkhisself posting FUD about TST..to me this is further evidence the cabel are traders and jerkhisself got caught short... ..most likely is this: a) TST received email notification from FDA (likley this am sometime after 9:30 am) b) TST calls for halt as it works on NR and gathers the BoD for a telecon to 1) review the FDA communications ...more  
Comment by conspiTheory on Aug 28, 2015 12:50pm
The June 2011 issue of Nature Reviews: Drug Discovery (volume 10, page 403) includes an interesting news brief regarding the apparent increase in Refuse-to-File (RTF) letters being issued by FDA in recent years. In a review of publicly available RTF letters, researchers at Leerink Swann found that 15 RTF letters were issued from 1998 to 2009 and that there have already been 13 issued since 2009 ...more  
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