Replies to post #21577 on Ocata Therapeutics Inc fka OCAT

[livingcell]

What if the AARDVARK took the wrong turning and ended up in Mexico. Hhahaha Just joking. Yes I agree. Would be nice to get a belated Christmas Gift.

[louisa]

Priceless. Just priceless. And quite funny.

Either way, the 30 day review time is well past. Even if they stuffed 9 volumes of safety data in saddlebags and strapped it to an aardvark it would have made the 350 mile journey long ago.

Meanwhile this is like waiting for the birth of my last child....who came a month early.(she felt compelled to admit)

[petekoz1]

FWIW, from Dan Schustack:

Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.

I'm saying that the "30 days to respond" is merely a guideline, not a hard and fast deadline.
Applicants must wait 30 calendar days. The FDA tries to respond within 30 days. Not the same thing.
Given the doubly sensative nature of the RPE IND (stems cells and human eyes) ACTC will not proceed until it hears from the FDA. At which point it will prepare a response and send it. Bill Caldwell stated in a November press release that he hopes that the FDA will be completely satisfied by the RPE IND by the end of Q1 2010.

Regarding the heart trials; it would require millions of dollars to run the Phase II. ACTC is still looking for a partner to fund and run that clinical program. As well as their other clinical programs.

Regards,

Dan