Good morning, most. I hope you have had a good wee

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Posted On: 08/18/2013 9:25:54 AM

Posted By: patientgal

Good morning, most. I hope you have had a good weekend thus far and have been greeted by good fortune in more ways than one. I vegged (well, vegged for me) after much needed yard work and mowing, with a Russel Crowe marathon.

So, I posted the below in response to Meach's post over in hell. I welcome all input and predictions. Well, so long as you don't try to start conflict that is.

From the 31 July PR:

"We are currently in the second round of discussions with the FDA. On May 20, 2013, we filed our answers to comments the FDA made regarding the trial design and preclinical data. On June 21, 2013, we received a second set of FDA comments stating several of their questions were adequately addressed, however additional data needs to be submitted," said David Koos, Chairman and CEO of Bio-Matrix Scientific Group (Regen's parent company)."

During my 17 July conversation with Dr. Thomas Ichim he was pretty adamant in conveying his confidence that Regen had satisfied the FDA's requirements with the most recent submission of information for what was the second round of Q&A. Since Dr. Ichim is in fact da man in stem cell research, not gonna question the validity of his confidence or ability to adequately provide research information.

So...21 June they received a request for more efficacy data. Sometime between 21 June (because I believe them to be workaholics, too) and spproximately 5:15 EST 17 July, data relating to the below had already been submitted (as per my conversation with the good Dr.):

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There was a 14 day pre-clinical study required to generate the submitted data. Let's say because they are workaholics they initiated the study on Saturday, 22 June. Thus it would have concluded on 6 July.

Judging by my own observations with respect to how efficient the Regen team can be (and that's pretty darn efficient, let me tell you.) coupled with what I know can be part of the process of transferring scientific findings into a government approved format, the submission would have been between Wednesday, 10 July and Monday, 15 July.

If the submission requirement mandates snail mail, the data would have been received the next day via overnight delivery. If electronic, the same day of course.

It is my firm belief that the company has to await written confirmation by the FDA before proceeding. I do not believe the 30 day "no news is good news" is applicable when there is Q&A (remember Q&A is very much normal and present with the vast majority of submissions). That being said, if in fact during the course of considering the efficacy data submitted, the FDA does not generate more questions based on their lack of knowledge in stem cell research (and compared to stem cell researches, there is A LOT the FDA does not know) then I would have to say the [u]decision or follow-up Q&A was determined[/u] Wednesday or Thursday passed.

This is just what I have come up with based on my experience in all this. As great as it would be to see an approval PR tomorrow morning BEFORE the market opens, I won't fret for I believe we will have it when it is meant to be had.