Ocata Therapeutics Inc fka OCAT

[rumper]

Phase 2 Pivotal is a Complete Slam Dunk !

And is very quickly becoming a mere formality.

It looks like PW and team, has coordinated with the
EMA and the FDA, to combine the phase 2 pivotal
trials.

Thus saving time, money, and effort.

This benefits the patients and the shareholders.

Stargarts and dry AMD patients are suffering with no
treatment available, Stargarts being an orphan and
dry AMD approaching an epidemic.

http://ir.ocata.com/press-releases/detail/2754/ocata-therapeutics-receives-regulatory-guidance-from
17 Mar 2015
"We are pleased with the guidance we’ve received from the European Medicines Agency which means that our SMD program can be initiated as a pivotal clinical trial, potentially allowing us to apply for marketing authorization upon its completion,” said Paul K. Wotton, President and Chief Executive Officer of Ocata Therapeutics who added, “As a result of these discussions we plan to enroll a total of approximately 100 patients, including an untreated control arm to more closely match guidance received from FDA. This would harmonize the development approach resulting in a more effective program.”
Ocata previously announced that it has been granted Advanced Therapy Medicinal Product (ATMP) designation for its RPE therapy for macular degeneration. The SMD program has orphan status both in Europe and the US.

THIS IS HUGE-NORMOUS !!!

Obviously, the citizenship of the trial participants makes
no difference to the disease. It's all about the data.

And regardless if the EMA and FDA trials are formally combined,
occur concurrently, or take place one after
the other, it's all a formality, once the very well designed
phase 2 pivotal is underway.


Cowboy 20/40, as I like to call him, achieved his stunning results
in 30 to 60 days, depending on which reporter you choose to follow. This patient was an elderly man whose eyesight had degenerated to worse than 20/400, some say 20/800. Following OCATs RPE treatment, after only 60 days, he had 20/40 vision in his treated eye, and he could ride his horses again. This is wonderful. I call 20/40 vision from worse than 20/400 a cure. You characterize it however you wish.

Q2 injections of the first 20 AMD patients will leave the entire
second half of 2015 to observe the results. These new patients
will be much healthier than the phase 1 patients.

I expect to see 20 examples of Cowboy 20/40, backed up by, before
and after, high resolution imagery showing the repaired RPE layer.
And all this in 30-60 days after injection. This therapy either works
or not after being injected. Because it's living cells, not a drug
that slowly coaxes the body to heal. It's tissue transplantation,
on the cellular lever. This is entirely new and it's brilliant !

It's one milestone reached after another with this company!
2015 is shaping up to be a historic year for our little Ocata.
Founded in 1994, left in the wilderness to suffer and persevere.
And only 20 years later on the brink of unimaginable success.
Nicely done!
Ocata, oh my!

btw, nsdq options !!!



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.21
(b) Phase 2. Phase 2 includes the controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects.

From Wikipedia, the free encyclopedia
A pivotal trial can refer to a clinical trial or study intended to provide evidence for a drug marketing approval,[1] e.g. by the US FDA. Phase III trials are assumed to be pivotal so the phrase is often used for the rare pivotal phase II trials.