Re: 3600 patient years
in response to
by
posted on
Feb 16, 2018 07:33PM
Absolutely - You seem to be giving DM a lot more power than is reasonable. "Slight of hand" in a medical trial, governed by 2 authorities, by a none medical person...really!
The Clinical Steering Committee and the DSMB design, set and monitor the trials. All members of those committees are Drs. No matter what you may have heard DM is not Superman.
FA/SSRA - You were at the AGM and heard the same words I did. From my meeting notes posted to this board on 18 Dec
Q: When do you anticipate getting the Futility Analysis results (or something to that affect)
A: Ours is not really a true Futility Analysis as with a very successful FA the trial could be over and ALL the patients could be put on apabetalone. I missed the rest of the answer but is was something like – that can’t or wont happen in this trial. (as they need this safety data in order to get the EMA approval). This will be a sample size analysis at 188 patients.
BDAZ has given you a good outline for when to expect a SSRA and 250 MACE events in his post this afternoon. The timeline that BDAZ came up with is consistent with the projected timeline the company has given us. DM can not rush or delay a scientific trial. It just has to play out as it is designed.
dyodd
tada