Chicagoest,

I don't have a good answer or even opinion for what is holding back the FDA from being involved in BETonMACE. Dealings with the FDA are outside of my realm of expertise. However, here is a recent post in response to Hartland regarding the status of Resverlogix and the FDA per Sarah, as well as past involvement of the FDA in the other RVX-208 trials to put things in perspective.

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Hartland,

G1945V posted on Stockhouse this reply from Sarah regarding your question about the status of the FDA approval:

"Yes we are actively working on Phase 3 approval from the FDA. Their process is different than that used in Europe and other counties and as expected will take longer. It is our policy not to publicize any discussions with the FDA while in progress and upon approval we will announce that particular milestone. Our main focus remains the BETonMACE trial and we are deeply focused on executing it in an efficient and timely manner."

On a side note, take a look at the Clinicaltrials.gov listing for the Phase 2 RVX-208 trials ofASSERT, SUSTAIN and ASSURE. FDA was a participating health authority for ASSERT as well as the earlier Phase1b/2a trial, but not for SUSTAIN or ASSURE. SUSTAIN was entirely run in South Africa and ASSURE was run in Argentina, Belgium, Brazil, Hungary, Netherlands, Poland, Spain and Russia. The diabetes trial was run in Australia. BETonMACE will be a great Phase 3 trial regardless of FDA approval. However, it sure would be nice if FDA came on board.

BearDownAZ