"I completely understand why there is no serious discussion on this board" If this is not serious what is? It sure is better than what you will find on the YMB.
Believe it or not, I was quite skeptical of the Junovan results in that first application to the FDA. IDM Pharma made the unprecedented move at a professional conference to request input by the participants as how to proceed in the analysis of the data that they had so far. That was obviously an act of desperation. Then, when they apparently figured out that the data indicated a positive result, they apparently did not include all the necessary paper work so that the FDA did not consider the extremely important recent data which might have changed the decision. Despite all this, I understand that a p value of .0625 was derived, although I am uncertain as to which "arm" generated that value. This, of course, fails a test where statistical acceptance is set at 95%. But, you know, I am still confused as to what exactly happened in the first submission to the FDA. When I asked Walbert at the last SHM, he changed the subject.
So, where are we now? It is quite simple - IDMI located the majority of the patients who participated in the study and found that, with this much simpler survivorship data set, that those who were treated with Junovan had better survivorship than those who did not. I understand (I don't have the documents in from of me) that the p value improved to < .05.
Exwannabe: since you are focused on the statistics, I suggest that instead of examining the old data that precipitated the FDA rejection that you consider the revised survivorship data where IDMI claims that as a result of Junovan treatment, patient survivorship had improved 30%. I do not know how this was calculated, but recent support for Junovan in a professional journal(s?) as well as the ODAC indicates that in the reevaluation by the FDA of Junovan that an approval will be forthcoming. Also consider that last week the FDA granted Compassionate Access, a mover that suggests to most followers of IDMI that full approval will occur this fall.
The only reason that I have stayed with IDMI is IDM-2101. I believe that IDM-2101 as well as Uvidem (?) will be many times bigger than Junovan and I look forward to when these two will complete their respective pIII trials. Considering the preclinical performance, PI and PII trials, I think IDM-2101 will be quite successful.
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