Regen BioPharma Inc (RGBP)

[cvinvestor]

How many posts will it take for people to understand that HemaX has to perform more safety trials and submit that data before there is a chance for FDA approval of clinical trials?

dCellVax IND is now front and center. Look over recent PRs. dCellVax success in demonstrating effectiveness in human cells and all experimental studies submitted with IND. What is different and hopeful here is that this is after previous phone calls with FDA cell experts, so it could be that Koos feels that they have all that they need for approval. At least we hope so and that the human cell experiment might have been a result of the request of FDA. Also significant is the patent application for dCellVax based on what they have learned during this process which may mean this IND is much more solid than the initial IND for HemaX.

Price should hold here better because we now have 2 products nearing clinical trial approval and only 30 days with possibility of FDA approval for dCellVax. HemaX is still weeks to months away since more data is needed for IND.

Indeed, I was thinking what we might see is either Orphan approval or FDA approval in about two weeks. This will be followed up with the eventual response from the FDA regarding dCellVax.

One question I do have is, given that the pre-clinical trials were submitted to the FDA with the IND, would we get approval to proceed with clinical trials? In other words, are we just waiting for an IND number or an IND number and FDA approval to proceed with clinical trials for dCellVax?