I did answer you. Where said answer is, I do not know.
Note: Though I do very much appreciate your confidence, the word "advice" is kind of scary to me as I am not a professional stock adviser. My position in this company is substantial, like many, and is based on my own dd and confidence in Regen. But I will be the first to admit I am no stock guru.
I guess that is my disclaimer.
To answer your question about when to expect FDA determination, it really can be anytime, in my opinion. The company PR'd evidence that they provided the FDA with the final bit of scientific evidence they sought in round two of the Q&A. Since efficacy was the point at hand and not safety, it would appear that they require no further information than that that was provided sometime before 17 July 2013.
As I have stated, if the FDA established a proviso at the onset that stipulated Regen must wait for their final approval in writing before initiating trials, one can expect it to be a minimum of 30 days before such confirmation is in hand. It is not a rule the 30 days in such a case. But it is sort of a given in these types of matters.
Now, if the FDA did not impose a proviso, Regen will be free to initiate trials 30 days after confirmation of receipt of the data by the FDA. I am guessing the 30 days to be somewhere between the 5th and the 14th of August if this is the case based on the 14 days required to complete the study for efficacy.
At any given time that any other country accepts their application for trials, Regen can initiate trials. They are ABSOLUTELY not bound by any law that requires them to commence such trials only in the United States. As a matter of fact, IF by some goofy chance the FDA denies them trials for HemaXellerate, they can begin trials elsewhere in as little time as it takes the other country to process the application. In many other places, such is in a lot less time that what the US requires.
There are a number of countries looking to assist in the treatments that Regen are trying to put in place.
Does this answer you questions?
