LOL, WRONG quote, "If they do them all at once, this will mean an accelerated
approach is being taken to collect the data and wrap
this up.
The RPE therapy is not a drug, it's an injection of living
cells, that amounts to a retina transplant. There is no
controversy about this. This drug trial will be like none
before it."
Too funny, IMO. Just make stuff up.
A phase II is not even REMOTELY CLOSE to "wrapping up" anything? It's where MOST DRUGS FAIL and get 100% rejected. It's a whole level up from a micro 18 person trial done w/ no control arm and the company itself 100% in control of all data and review, etc. Phase II's, large ones are the "TRIP ZONE" of the drug approval process.
Then, if they even make it through phase II in YEARS FROM NOW, then comes the lengthy and very large PHASE III, a few more years to complete and then "try" and submit to the FDA "if" the FDA doesn't ask for more trials, different data, etc.
This is barely out of the starting gate in the attempt at an FDA approval.
And YES, the FDA SAYS IT'S 100% A DRUG, DRUG, DRUG. Not even debatable- and OCAT knows it and is designing and trying to line up funding for lengthy and expensive FDA DRUG clinical trials. There is ZERO PROOF OTHERWISE, NONE EXISTS.
Per their own insider's "on the record" statements to a local MA newspaper- year 2020 is a "maybe" for an attempted approval of their DRUG process/treatment. FIVE long years and probably at least $100 MILLION or more away from March of 2015.
FACTS versus made up mythology and conjecture and just pure fantasy talk.
www.telegram.com/article/20141014/NEWS/310149525/1237
Quote from the MA newspaper journalist interview speaking DIRECTLY TO LANZA- who I'd say knows what he's talking about (DRUG and year 2020) versus anyone else "commenting" on the subject:
"Advanced Cell now hopes to launch a 100-patient, phase 2 study in Stargardt's patients by the end of the year, according to Dr. Lanza.
A second, smaller phase 2 study in patients with age-related macular degeneration would follow, he said. Any treatment might not be ready for FDA approval until 2020, Dr. Lanza said. "
Meaning yr 2020 is the "fact track" and a "maybe" according to OCAT's own top insider. CLEAR- he's quoted verbatim by a print journalist and OCAT never disputed it or asked for a retraction of that statement.
