Regen BioPharma Inc (RGBP)

[cvinvestor]

Very true that most of us are not aware clearly of the entire process, but there were some that claimed to be part of the industry who also claimed a much quicker turn around for everything, so, I must admit, finding out they just submitted the final FDA response is disappointing.

That said, it is also good to know that the lack of FDA news was not a sign of lack of FDA approval, but instead, no opportunity for FDA to approve since they hadn't heard from RGBP.

Note that the PR also said they included data on the clinical trials, so that might mean that there has been some changes in the proposed clinical trial procedures or location. I see this as an optimistic sign that with RGBP's new relationships and new SAB members, that they may have a better location and working relationship to do the clinical trial than what they had when they submitted the IND. I think the clinical trial arrangements and protocol with GLP might be more reason for the delay than the prep of the CRL data.

Just a guess.