ITMN said they would meet with the FDA withing 3 months of the letter they received - a positive since it was not an absolute turn down. I remember that date was around May 4th so we should see a meeting in early July. There is also the possibility that they can use test results from Japan. Could be this why Balyasny increased his position. Perhaps he feels this stock will go up BEFORE the meeting?
Here is a link to the documents referred to in my post.
The company and the posters on this board are perpetuating wishful thinking.
THE CURRENT NDA IS DEAD!
New trials, conducted better with a survival end-point just as the company was told by FDA the last time around is required.
There is no point even considering a trial for pirfenidone with a mortality endpoint (well, maybe if you drop the significance level to 70% from the usual 95%). The study size and duration needed for 95% statistical significance are infeasible. FDA insistance on such a thing would be much the same as a statement that the drug could not be approved under any circumstances.
There's probably still time to let your senators and representatives know that you think FDA ought to go easy on the only drug shown to be helpful at all against IPF. Those sentiments sometimes get passed along.
also they have two phase 3 trials complete and another to be complete next may, that should supply enough data to satisfy the fda. Plus one additional p3 trial, but I didnt check the completion date
Thanks - That would be August. Something was also said about the difficult task of transcribing the data from Japan. Why would that be so difficult? Maybe I am missing something here. The drug passed all testing requirements in Japan and is being used successfully. Are their testing standards different? What exactly is the problem with using their test results? Too bad someone on the panel at the FDA doesn't have a close family member that needs this drug!
The format of Japanese approval testing is different from what FDA mandates. It is possible that FDA might give in on that. But there are two other issues: they would require English translation of all hospital charts connected with the study (translation of short illegible technical comments full of abbreviations and jargon is no picnic); there was apparently a change in the middle of the Japanese study, which FDA pretty much never tolerates in registration studies.
I agree--pressure from affected families is very important in getting pirfenidone to patients. But I wouldn't wish IPF on a stranger.
That would make ninety days early August right? Anyway, we haven't heard anything about a scheduled meeting with the FDA so hopefully we will get some idea of a date pretty soon, who knows.