Re: Financials are out
in response to
by
posted on
Jul 30, 2018 10:50PM
They mention the SSRA at 75% of events 4 times in the MD&A. Although they may opt to not perform the SSRA, I interpret these MD&A statements to indicate that: 1) 188 MACE events have not yet been adjudicated; and 2) the decision to perform or not perform the SSRA has not been made yet.
If true, it is looking unlikely to hit 250 MACE event target by year end. Lower than expected overall event rate in this patient population? Incredible MACE reducing effect of apabetalone? Some of each? Hopefully mainly an apabetalone effect! George, this delayed event accumulation could be the reason why the sales debut prediction is pushed back.
I would have liked to see an official statement in the MD&A about all patients continuing on drug treatment until end of study, but I didn't see it. The ClinicalTrials.gov page hasn't been updated with this change either. I think it was just the ERA-EDTA and AAIC posters that reflected this.
"We have enrolled approximately 2,400 patients as outlined in the study’s protocol." So seems that enrollment is complete as previously press released, barring any changes implented as a result of a potential SSRA.
Renal and Fabry trial still planned for 2018.
Not too much new in the MD&A, but the statements on enrollment and SSRA give some indication of where things are at.
BearDownAZ