TELESTA THERAPEUTICS INC T.TST

What Came Out of the FDA Meetings ...

[silvarline]

In terms of Trial IIIB design, timelines, size and participants? Things seem to have got dropped ... touts site! From the April 8th PR .. "As part of this succession plan for MCNA, Telesta will continue to work with the FDA in the months to come to precisely define the exact parameters of the clinical trial that will be acceptable to the U.S. FDA so that the exact costs and timeline of the trial can be quantified for the eventual partner or third party...." Mmmm ... inquiring minds would like to know, the details of the FDA discussions.

[Mikepal]

Would be good to know why Ispen walked away? Or are they coming back now that the .14 line in the sand has been drawn? And will they be ready to pay the 2.5 Mil fee to break the deal with the PLI - Inquiring minds would like to know the details of the FDA meetings

[NearlyDone]

What I got out of it is that MCNA was re evaluated in the context of a second P3 and because it would be 5 years long and not easy it was just written up as worthless. That is pretty much the way it was summed up in the August 2 release where the plant was shut down + all manufacturing staff layed off + Ipsen left + MCNA was shelved without saying anything other than telling us that they are