Regen BioPharma Inc (RGBP)

[cvinvestor]

Please consider the context surrounding all quotes.

The PR title was on the Experimental Protocol, not clinical trial protocol which we've been told is already approved. The only question remaining is proving the safety in the way the FDA wants.

Here are the 2 sentences after the phrase quoted which clarify the issue of the experimental protocol:

The protocol submission was the result of a telephonic meeting with FDA officials, in which the Agency permitted the Company to provide additional input on preclinical safety experiments that need to be conducted before the clinical trial is initiated.

"The most important aspect of any novel therapeutic utility in humans is safety of the experimental product. We are grateful for the cooperation of the FDA in working with our scientists in ensuring the appropriate preclinical experimentation is performed, so as to minimize risk to the patient population," said David Koos, President and CEO of Regen BioPharma.

The PR is very clear that the safety experiments talked about have not yet been performed. Additionally, these experiments are preclinical.

If the company progresses without setbacks, maybe we can expect:
a. A PR regarding IND submission of dCellVax (any day)
b. A PR regarding preclinical test protocol affirmation of FDA and initiation of HemaX safety tests in GLP lab (1-2 weeks)
c. FDA feedback on dCellVax IND (October)
d. A PR talking about progress/positive results within HemaX safety tests (November)
e. PR about resubmission of dCellVax IND to meet requests of FDA comments (December)
f. HemaX safety test results submission and clinical trial approval - (1st Qtr 2015)
g. PR regarding dCellVax clinical trial approval (1st Qtr 2015)

This is all a projection based on common sense time factors involved in the process based on information we have to date and the reality of the FDA process. Any setbacks would extend this timeline out further.

I think if the above timeline can come to fruition, it will result in 2015 being the year everything changes for BMSN/RGBP in regards to investors, trust, optimism and steady progress forward with exciting possibilities. This is assuming the company has had a change of heart and is willing to be transparent in the process going forward.

AIMO