Yea sure, I can help you understand that...
The BioRestorative facility we are talking about is not being created to produce the product for mass distribution but to create the necessary amount of product required to satisfy the needs of the clinical trails. There will have to be enough product created for the subjects/people who are part of the clinical trails and that's what this is about and once they get the funding, they had better have a facility in place in order to be ready to go! This is great news!!!
They also will need absolute authority over the production of that product in order to make sure it meets the standards put forth by the FDA. Please note: the FDA oversees every aspect of the trial. So obviously, the company will need it's own facility and for more than one reason.
At some point in the future, production most likely will be farmed out to a manufacturer for mass distribution because of the fact that BRTX is not a manufacturer, they are a R&D laboratory plus, plus, plus. For example, Mesoblast, a competitor in the stem-cell disk therapy realm, uses several different manufacturers to build and distribute their products. We can expect the same.
As is the earlier version of the Disk program, the FDA reserves the right to fast-track testing like they did with bypassing the Phase ! testing of the BRTX Disk program because of the high level of anecdotal patient success. Fast Tracking is again possible with regard to the move to the Phase III testing and thereafter, to the public sphere. If you know anything about the FDA, you will understand the fluidity of the testing relative to the time to market. It can be very fast or take forever so the timeline here is merely an estimate. If this is highly effective, which is is BTW, we can expect it to go to market much faster, however, to be realistic, Mesoblast's disk product took four years. Also, Mesoblast's product is not nearly as effect... NOT EVEN CLOSE!
Just funding and beginning the testing will show enough intent to push the stock price up.... I am absolutely certain of that!
Pro-Advisor
