Rivulet Media Inc (fka RIVU)

[cvinvestor]

Please read the PR - protocol is for experimental safety testing that needs to be done before FDA can review and approve the IND clinical trials.

Both drog68 and d5wr59mfi8's response are not reflective of the PR.

drog68 post# 144319
Post # of 144364
IMO, IND submission tomorrow or next Tuesday, followed by FDA news.

The IND for HemaX was filed in Feb 2013 with variations/updates refiled on several occasions. What this PR gives us is a little more transparency that the new saftey tests for HemaX requested by FDA phone call have NOT BEEN FILED as I previously posted in response to the wording of previous PRs. HemaX is most likely still a few months out before clinical trials can be approved, depending on what the safety experimental model protocol requests are (could be 4-5 months for toxicity tests based on previous timelines given).

What we can anticipate is an IND for dCellVax within the month I imagine, then a month for FDA response and then either approval or we get a similar PR about further tests needed. The PR after FDA reviews dCellVax will tell us more about whether Koos and Ichim have learned and gotten a better grasp of the IND process or not, based on whether IND is approved or needs more...


Please read what the PR actually says: [What I like about the PR today and I hope continues is the fact of more communication and greater transparency of the progress of the company in relation to the INDs. Investors need updates on progress of company, whether good or bad. When months go by without any news even though timelines for milestones have passed, it's worse than getting the actual bad news on time and big money will not come because they cannot trust to learn what is going on in a timely manner. If we start getting updates on important steps and delays as they happen, it will allow for confidence and trust to follow on good news.]

But don't expect any gap up in price tomorrow, nor any heavy sell off as today's PR confirms what was obscurely inferred in the last PR with the update that RGBP has submitted a proposal for FDA review to begin the necessary safety experiments needed before HemaX can be approved for trials.

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.