RE:RE:RE:fun challenge to any true believer up to the task...Hello, guys...This is how Sarah responded. You be the judge of it.
I questioned the following on Oct 31:
Hello, again Sarah. Are you able to tell me;
a) if as yet RVX actually applied for ODD with the FDA and if so can you give me the date when it was done. It is my understanding that once
an application is received by the FDA they have 90 days to respond.
b) and can you confirm that the BetOnMace trials actually begin when the first patient is treated ( or dosed ) and if so what is that date,
c) or does it actually begin when the patient selection preparation starts and if so has the patient selection started and if so when did it start. .
Your earliest response would be greatly appreciated.
Regards,
________________________________________________________________
Sarah's response on Nov 3:
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.
With regards to your question on BETonMACE; yes the trial has commenced as announced in our recent release. We have sites open with drug on-site which means enrollment and screening of patients has now commenced.
Best regards,
Sarah