Feb 5th - IND applied for (mailed in, we don't know)
30 days for FDA review and mail back.
So let's say 36-39 days from mailing IND to getting a response or from Feb 5th to March 13-16.
I don't if anyone else did, but I contacted Regen through their website last week saying the 30 days was up and as an investor, we should know the material results of the IND application.
Not saying that my contact necessarily triggered PR today, but certainly they knew that they should do something.
Fact that IND wasn't approved outright, indicates that there was some type of "problem" with initial application. Incomplete or needed more forms or FDA needed clarification on something...
Remember, FDA gave Pluristem orphan status approval for aplastic anemia research just a couple of weeks ago. (More than one company can have orphan status approval until one of them gets commercialization approval which then gives exclusivity for 7 years).
So, seems clear to me that BMSN won't be making sustained big moves one way or the other until the IND is fully approved (or they fail to answer FDA's concerns sufficiently, which doesn't seem likely at this point for a phase I/II trial, especially for a disease that doesn't have a remedy).
However, since aplastic anemia is fatal within a short period of time and BMSN is new to the whole clinical trial phase, it would not be surprising for the FDA to make sure BMSN has all its I's and T's dotted and crossed before dealing with people who are about to die and who might die during the clinical trials.
Therefore, as many on the board have said, today's PR is just a communication to say "we've applied; it's been received and we are working out the details with the FDA over their concerns before getting the green light".
More than that, it's a guessing game as to when the green light comes. I'm thinking it could be 1-2 weeks. If it was hours or a couple days, they would have held the PR until full approval. If the door had been slammed in their faces, they wouldn't (or shouldn't) have released today's PR with the language in it.
So I'm guessing we have to hold for a couple more weeks, hoping that BMSN's team did enough pre-IND research ahead of filing to be able to smooth out and put in place what the FDA needs for full approval.
More than that, it's all speculative.
