re "
You STILL haven't answered the questions."
As a recap, here is 1 question you think has not been answered
"
Why would the Data Monitoring Committee allow the trial to continue .. if Teva saw an indication that persuaded them to leave in the 1st interim
?"
The ceo made the following comments about the 1st interim at
10:46.
"
Surrogates being systolic and diastolic volume and, as I said, we saw very dramatic effects in the phase 2 trial so if we see similar directionality in the first interim then we'll be very pleased in terms of the administrative look".
That should rule out any doubts anyone has that there was no check of surrogate endpoints. In the same discussion the ceo agrees that this is a look at efficacy through the
secondary endpoints, this was not a look at the primary endpoint.
In making that point he is reflecting
that the trial would not be stopped for reasons of efficacy in the 1st interim - the DMC would have only stopped the trial at this point if there was a safety issue, this point has been made elsewhere. I don't think anyone is suggesting there is a safety issue.
That Teva wanted a yes/no answer on secondary endpoints readings, and the fact that the trial was not stopped by the DMC for safety reasons are 2 distinct things. The futility analysis for stopping the trial will be part of interim analysis 2
So the answer to the question, the DMC saw no safety reason to stop the trial but there was an independent reading of surrogate efficacy taken that Teva requested and, in my view at least, almost certainly provided the reason they terminated the partnership. I have other reasons for thinking this which I have included in earlier posts
This is highlighted in the agreement at
http://www.sec.gov/Archives/edgar/data/1345099/000119312515361222/d943277dex1031.htm) and in particular with this paragraph with my emphasis on point 1 and ,again, the safety only aspect in point 3
""
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."
You might then think that these secondary endpoints are not relevant. In the earlier quote you saw what the ceo thinks "
Surrogates being systolic and diastolic volume and, as I said, we saw very dramatic effects in the phase 2 trial so if we see similar directionality in the first interim then we'll be very pleased in terms of the administrative look".
In my opinion, Teva thought the same, they wanted to see evidence of good results from these readings, they did not see what they wanted, so they walked away.
the other question you thought had not been answered :-
"
why would MSB choose to throw another $13million down the toilet?"
This is what the company said
most recently about the $13 million
"
The results will be used to provide evidence based support for strategic decisions regarding the Phase 3 program, ongoing cardiovascular partnering discussions, and informed use of funds."
In my opinion, "
informed use of funds" means, unless what they see is extremely good on a patient number considerably less than 600,
or a partner pops up to save the day, this trial will wind down.
Compare the above quote to what Mesoblast had said about the 2nd interim
before Teva terminated the deal - reads a bit differently I think, no funding checks, and clearly, at that time, no concern about a missing partner.
"
Additionally, a second interim analysis will be performed in the ongoing Phase 3 trial when 50% of the HF-MACE have occurred. We expect the outcome of the first Phase 3 interim analysis for safety and efficacy in the first quarter of 2016. We expect the second interim analysis for futility, resizing and possible overwhelming efficacy in the first quarter of 2017."
(20min delay)