"So on what basis can anyone claim that Teva has no confidence in efficacy?
(I explored this possibility because its the only one I could think of given that the FDA has approved continued progression of the trials.)"
I am glad you mention this because I have been wondering about it myself. Incidentally the DMC gave the recommendation to proceed. The ceo has said that neither Teva or Mesoblast have seen the efficacy results.
However the deal - http://www.sec.gov/Archives/edgar/data/1345099/000119312515361222/d943277dex1031.htm) - around the 1st interim included the following
For the surrogate endpoints analysis, the predefined threshold will be achieved if the following two conditions are satisfied:
a) The difference in mean change from baseline to month [***] between CEP-41750 and the control groups for [***] is greater than or equal to [***]; and
b) The difference in mean change from baseline to month [***] between CEP-41750 and the control groups for either [***] or [***] is less than or equal to [***].
The Statistician will evaluate the results of the surrogate endpoints analysis and incorporate them into a written notice to be sent to each of Mesoblast, Cephalon and the ESC as described in paragraph 5 herein.
"For the avoidance of doubt, Cephalon shall have a right to withdraw from the P3CHF Trial only if (1) the Statistician determines that the surrogate endpoints set forth in paragraph 3 above have not been achieved; (2) fewer than [***] patients have been enrolled in the P3CHF Trial on the date [***] months after treatment of the first patient enrolled; or (3) any regulatory authority, data safety monitoring board or IRB requires such termination as a result of safety issues."
paragraph 5
"The written notice will consist of a binary notification (yes/no) of whether the respective thresholds were achieved."
So my question, did Teva and Mesoblast get this yes/no indication about the "surrogate endpoints analysis" as the above suggests they did? Regardless, now Teva have walked, what assumption do you think the market will make about this result? I doubt they will assume it was a "yes".
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