We have been through this before on previous occasions.
I take it you are talking about (PIII) efficacy trial Nasrat indicated the FDA may require. The ADT pharmacological approach was something the FDA had not seen before and he was waiting on FDA guidance as to whether the trial would be required.
It is ludicrous to criticize Nasrat for not proceeding with the PIII (and spending millions of dollars) when there was a possibility he would not have to do so.
"And that is the subject that I have mentioned many, many times to everybody before. I am going by the letter of the law and we have done everything that we believe the law requires. The FDA keeps coming back that they may want to see an efficacy and that’s what we’re negotiating with them. If they do and as I’ve said I have anticipated that they may ask for it, [indiscernible] there are certain things I may or may not ask for. And if they do that is what I have said, they will delay us by a few month but they will not stop us because everything else we’ve done has been to their liking."
"Trust me we’re ready to file next month, but we are not in such rush to file with the FDA and they come back three or four months later. We really wanted to do this one little thing but it will take three four months and end up delaying this badly. So we are waiting for the FDA and they promise expedite things to give us a clarity on what’s acceptable and what -- I shouldn’t say what’s not acceptable because everything has been acceptable to them. It’s the fact that they have never seen any product like ours before and they may ask us for some enhancements or couple of extra things and I can just say to you guys and update you guys on it before and once they make that decision that really will set things in motion but it just are facts [ph] that will happen one after the other."
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