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Wednesday, April 21, 2021 8:46:42 PM
RGBP passed through Pre-Clinical a long time ago on their immune modulating cancer therapy patent that operates via mRNA. Upon completion of this Pre-Clinical they immediately turned around and filed an IND. (See #1 & #2 Links).
1).
https://pipelinereview.com/index.php/2016032360757/DNA-RNA-and-Cells/Regen-BioPharma-Inc.-Submits-IND-Application-to-FDA-on-tCellVax-a-Checkpoint-Inhibitor-for-Cancer-Therapy.html
2).
https://www.biospace.com/article/releases/regen-biopharma-completes-preclinical-experimentation-for-its-sirna-nr2f6-checkpoint-inhibitor-/?s=83.
There are many factors involved in getting FDA approval for an IND and it's up to the examiners to grant it which they determine on a case by case basis and are not obligated to do so.
Also, an IND can be opened at any stage of the development process, BUT can NOT advance to Human Subjects in Pre-Clinical without FDA approval.
http://www.impactpharma.com/blog/before-you-file-your-ind/
However RGBP did in fact complete the Pre-Clinical Testing several years ago, again for the above mentioned patent which positioned them for where they are today...in partnership with a Big Pharma for advancing their candidate cancer drug patent onward into production and commercialization however I am not aware of when they completed Phases II-IV for this patent, but apparently they did OR they have been granted a provisional go ahead based on the FDA's Fast Tracking provision for urgent need pharmaceutical applications like what happened with the Covid Vaccine.
No matter how anyone looks at it, RGBP has a Big Pharma partners AND has already licensed out its above mentioned patent for production.
I don't claim to know everything about this company BUT I do know where they are today positoned in the Big Pharma market, which is undeniable!
I hope this helps, but please keep in mind that this company has A LOT in their Patent Pipeline that are presently under development but I am not appraised of what stage of development these are at currently.
Be well and prosper...
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