FDA Reviews Interim Data from Blinded Phasell 'Pee
Here is a quote from Elans Q3/07 CC to help understand how they are able to proceed with a Phaselll Trial while the Blinded Phasell is still ongoing. I know bioboffin is interested and perhaps many others. I have a few quotes about this and also about what endpoints the FDA wants fro Alzheimers and will post them as time permits.
The company analyses the interim Trial Data and the FDA is Privy to the Data as well........ all the while the Trial remains Blinded.
I Capitalized the parts more relevant to the subject of the Third Party 'Peek'.....
.....Elan......"Bapineuzumab or AAB-001, our lead immunotherapeutic candidate Phase II trial is ongoing, with the final data anticipated in mid 2008. In parallel we are conducting a smaller Phase II imaging study in the EU as well as a Phase I trial in Japan. I WOULD REMIND EVERYONE THAT THIS PHASEll TRIAL IS BLINDED AND WILL REMAIN SO UNTIL ITS COMPLETION IN 2008.
And finally I'll provide a brief update on the clinical and regulatory status of the impending Phase III trial for Bapineuzumab. In the regulatory arena most of the FDA and the CHMP have agreed that the companies can proceed to Phase III. During the late September meeting the FDA agreed in principle for a proposed Phase III trial design.
AS PART OF THIS DISCUSSION THE FDA HAD THE OPPORTUNITY TO REVIEW DATA FROM AN-1792, THE PHASEl DATA AND THE INTERIM DATA FROM THE CURRENT AND ONGOING PHASEll TRIAL. All of which were relevant for the design of Phase III trial.
In the EU, we recently received an advice letter from the CHMP where they agreed to proceeding to Phase III with minor adjustments.".....
This could happen with AZD-103......Dr. Cruz has talked about it publicly before........Yup
GPP ALL