20/20 On RGBP's FDA Approval For Clinical Trials
Regarding my statement:
"This Patent is already in the BAG! If not, it would NOT of been FDA approved for entering Clinical Trials."
The FDA rigorously scrutinizes all Patent applications for an IND via a Medical-Scientific Board commonly referred to as an "IRB" or Institutional Review Board.
The IRB is composed of leading world class experts in their various fields, i.e. published & lectured, M.D./Ph.D. Clinician-Scientists who possess authoritative knowledge in the specific areas of each Patent Application, i.e. the relevant underlying science including the proposed clinical nuances.
Many of these professionals were involved at one time in the development of pharmaceuticals on the market today and they ALL have a broad history of publishing in peer reviewed medical/scientific journals and/or hold (or have held) faculty positions at various Medical Schools or University Graduate Programs leading to advanced degrees in the Sciences. Others have career backgrounds that have included siting on the Board of Big Pharmas and were directly involved in Intellectual Property Patent Development, i.e. Big Pharma I.P's. These are authoritative scientific professionals in their own right.
All the above is just to give everyone here an idea of who these people are that sit on the FDA Review Board for approving or rejecting INDs. I know from first hand experience throughout my 30+ Year career as an M.D. clinical trials professional involved in both the design & conduct of clinical trials as a Principal Investigator who has had extensive involvement for decades in the FDA mandated IRB Board Review Process for initiating INDs into Clinical Trials, i.e. post approval on an IND Application, and therefore I am thoroughly acquainted with scores of FDA approved INDs relative to the scientific-clinical merit of those approvals that I am required to thoroughly understand in order to design clinical trials protocols for bringing those INDs to Market. That's what the core of my professional experience is all about...bringing INDs like RGBP's NR2F6 Patent to Market via Phase 1-IV Clinical Trials the results of which must also be reported to the FDA including answering any of their inquiries.
Those experts chosen by the FDA to sit on their internal IRB possess the exact same level of scientific & clinical knowledge expertise (or greater) than the individuals who developed the Patents. Is it making sense now???
So the FDA review process is NOT conducted by one person reviewing a Patent for approval. Instead, it's a highly qualified Medical-Scientific Board.
When they vote to approve ANY Candidate Drug Patent for an IND it must be by unanimous vote and IF that doesn't happen the Patent is rejected for entry into Clinical Trials!!!
This is the reason why only about 1 in 10,000 Patent applications for an IND get approved by the FDA for entering clinical trials, meaning they are near 100% certain that the extremely limited number of Patents they approve will more than likely transition successful through all phases of clinical trials and will be effective pharmaceuticals for various treatment applications.
Sometimes these FDA-IRB reviews can last for several months and in some cases years via multiple re-submission IND requests with further validating information to support the Patent requested by the FDA Board.
During this process they're known to send a battery of written requests for clarification of various areas of the underlying science that can extend to questioning the methodologies that the science was derived from, and even the various statistical models utilized in data analysis that should be based on linear regression.
It is an extremely rigorous lengthy process that results in MOST Patent Applications for an IND being OVERWHELMINGLY REJECTED!!!
This is the reason why only about 50 Patent Applications to the FDA for an IND out of 10,000 make it to Market. Importantly, this estimated number (50), represents about 95% of the Patent Applications that received FDA Approval to enter Clinical Trials like RGBP. It's almost the equivalent of hitting the LOTTO!!!
The take away:
The possibility of RGBP passing successfully through ALL Clinical Trial Phases (I-IV) and making it to Market is HIGHLY PROBABLE!! It's at least a 95% probability! If NOT, it would of never been approved by the FDA for Clinical Trials from the GET GO!!!
I hope this information helps dispel doubts from naysayers about what this company has and reveals the extraordinary success made by RGBP in getting FDA Approval on their NR2F6 Patent for Clinical Trials; something that happens next to NEVER!!!
My advice??? KNOW WHAT YOU OWN!!! In this case it's a Gold Mine for which the current PPS trading range for months has absolutely nothing whatsoever to do with. It's is a function of Market Manipulation.... nothing more, and that manipulation is in its last hour beginning with Pink Current.
On the horizon after that... OTCQB then NASDAQ.
Lastly IMO, what should of happened with this company from the beginning is open on NASDAQ as an IPO. That could of easily been done with the caliber of Patents RGBP owns, all of which represent Disruptive Biotechnology.
Disclaimer: All the above is a personal opinion only but one that's drawn from decades of professional experience.
Be well and prosper...
