VU ...the prepared statement by Granowitz at the start of the CC was as follows
" The population being studied in REDUCE-IT with well-controlled bad cholesterol, but other CV risk factors and without potential benefits of Vascepa was assumed in the design of the study to incur major adverse cardiovascular events at a rate approximately 5% per year."
In previous statements the Co had stated something to the effect that " by adding 1,000 more patients to the trial design the placebo rate could be as low as 5.2% "
I follow a number of biotech co's and am admittedly some what jaded re mgt comments ...but to me Granowitz could have easily restated the previous company line ...... "placebo rate could be as low as 5.2%".
As I stated ...this was in the prepared comments section of the CC ...not as an off the cuff response to a question.
Anyway if you have time could you explain your modeling . My understanding of bio stats is limited .
IF the placebo rate does in fact turn out to be 5% and the active arm rate turn out to be 4.25% ...ie a 15% reduction ...why is that a failure ?
Does it have to do with number of patient yrs etc ...which they are being vague on ...
They have only really committed to readout data in Q3 2018 ...so that could be even as late as end of Sept ...so they could still be continuing site visits and recording events into the end of May ....or have they specified an absolute cut off date ?
I suspect this will run longer then most anticipate...and if it does, would it enable a 5% placebo , 4.25% active arm rate in your model ?
By the way ...not all trials run as designed ...the FOURIER trial for PCSK9i being I believe the most recent CV trial example.
Appreciate your thoughts
Kiwi
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