Regen BioPharma Inc (RGBP)

[cvinvestor]

Here's my two cents for the day on today's PR.

Read the PR slowly and for what it says in the context of all that we had been informed of via PRs this year. Kesari, (brought on SAB in April along with 2 others and then on May 27 RGBP PR states filing of new IP patent regarding dendritic T cells).

After that I posted the following: Post #14018

I agree on the probability of a dCellVax delayed "response" to FDA questions which might result in an altered IND or a completely new IND for dCellVax. Human clinical trials are expensive and only good for the specific IND you submit, so the fact that dCellVax will need GLP testing and the fact that hasn't yet been mentioned as part of the response, I interpret as a sign that recent developments and improvements in aspects relating to dCellVax are substantial enough that they are waiting to finish their laboratory testing to see if a "new and improved" dCellVax application with much higher chance of success can be finalized before responding to initial IND. Whether that creates a new IND or not I cannot say, but at this point I don't see the delay as a factor of incompetence or a setback, but rather because of the recent significant developments they've discovered that warrant delaying dCellVax so as to improve it significantly.

Also see #14009 on quote from new IP patent PR.

Today's PR confirms that in light of the original dCellVax IND, FDA questions and further research by RGBP, RGBP announces that Kesari is to take a more active role in both modifying the dCellVax IND and setting up the proposed dCellVax clinical trial protocols as regards to safety and efficacy. Remember, all this new immunotherapy cell based "drugs" is an emerging field for which the FDA doesn't have an established "rule book" to quote from and to follow. So the FDA itself has questions on "how do we know if this treatment is successful or safe and won't have long term side effects with all these new cells remaining active, multiplying etc."

Today's PR states nothing and indicates nothing regarding pre-clinical saftey testing. It doesn't address it. The PR also doesn't address entirely what aspects of the IND would be changed, i.e. solely in regards to clinical trial protocols and indicators, or also in regards to the make up and application of dCellVax in regards to the 2nd generation potency/combo treatment. If only clinical trial protocol, no further pre-clinical safety testing would be needed. If IND changes include changes of dCellVax application, then additional safety data might need to be submitted.

Once again, we have news and news which indicates further chance of progress having established experts dealing with FDA questions, but we do not have anything to judge timeframes on.

This is good news in general, but as to short term significance, we have no time frame. Only confirmation that while CRL goes forward with HemaX, dCellVax and other possible pipeline products continue in their development.

PS. Given today's PR info, we can now read a little more into Kesari's being added to Scientific Advisory Board (along with other 2 doctors) in April was most likely a targeted move to help advance dCellVax. Likewise the timing and hiring of the 3 recent retinoic acid specialists might also mean that an IND for NR2F6 is very close to being established and formulated - certainly encouraging that it could happen before end of year which does raise possibility of RGBP having 2 or 3 approved INDs by end of 2015 - now that would be a BREAKTHROUGH YEAR indeed.