Ocata Therapeutics Inc fka OCAT

[rocky301]

bballer and all,


While examples have been cited here that seemingly contradict the 30 day review process I decided to do some work on Geron's IND which is most closely related involving hESC's. First of all, Geron did not diclose via PR when they filed their IND so I had to do some backtracking. From the 4 items I listed below I have the following conclusions.

Geron filed their IND between March 21-31, 2008, paid their milestone payment on April 21, 2008(within 30 days of IND), and received verbal notice on May 14, 2008 the IND was placed on a clinical hold. Using the March 31 date for filing and verbal notice of hold on May 14 we have 44 days(at minimum) that passed before FDA verbally put them on hold. Very close to where we are at now.

My point in all this? The FDA Clearance to move forward is huge, without it nothing else takes place. I cannot fathom that ACTC has received clearance and not disclosed, it makes absolutely no sense to me. Bottom line, IMHO, I doubt a clearance or a hold has been disseminated to ACTC at this point. From Geron's example and others cited it would seem some news is close.

___________________________________________________________________

The clearance of the clinical trial — of a treatment for spinal cord injury — is to be announced Friday by Geron, the biotechnology company that first applied to the Food and Drug Administration to conduct the trial last March. The F.D.A. had first said no, asking for more data."
http://www.nytimes.com/2009/01/23/business/23stem.html?_r=2


"MENLO PARK, Calif.--(BUSINESS WIRE)--May 14, 2008 - Geron Corporation (Nasdaq:GERN) announced today that the company received verbal notice today from the FDA that the company's Investigational New Drug (IND) submission for GRNOPC1, a cell therapy for spinal cord injury, has been placed on clinical hold."
http://www.drugs.com/news/fda-places-geron-s-grnopc1-ind-clinical-hold-8193.html

(page 37)
On April 21, 2008, as payment of the milestone achievement for filing an Investigational New Drug application with the Food and Drug Administration for Geron’s human embryonic stem cell-derived oligodendrocytes (GRNOPC1) for the treatment of spinal cord injury, we issued to Wisconsin Alumni Research Foundation (WARF), 47,207 shares of our common stock, pursuant to a License Agreement dated as of January 8, 2002. The total fair value of the common stock was $224,000 which has been included in research and development expense.
http://www.sec.gov/Archives/edgar/data/886744/000115752308006205/a5742218.htm

(page 5)
Geron Milestone payments for filing IND "within 30 days of event"
http://www.docstoc.com/docs/17599014/Agreement---GERON-CORP---1-21-2000