Post by
silvarline on Aug 29, 2016 9:53pm
What Came Out of the FDA Meetings ...
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.
Comment by
Mikepal on Aug 30, 2016 8:47am
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