Since we're speculating
posted on
Jan 05, 2018 05:21PM
Great conversation today, all points of view are valid.
If they believe that the results they are going to get from BoM are going to knock it out of the park and they need to have the safety data from a completed BoM trial there could be a large dilemma here. They need this safety data for the EMA approval. At the AGM there was about 2100 recruited for this trial leaving just enough space for what they thought at the time, 300 recruits from the USA. Now under "new rules" they only need 100 recruits from the US, they think. We will hear more on this shortly as there was a meeting scheduled with the FDA in early Jan(any day now). Once they know what the FDA requirements actually are then they can proceed down that path, rapidly. I'm going to make a couple of assumptions here, 1) There are 20 or more clinics in the US that are up and ready to recruit. All of those clinics have all of the publicly available data on safety and efficacy of apabetalone published so far and maybe a little that hasn't been published yet. This data should assist these clinics in their recruiting efforts. 2) Other clinics that are currently participating in the the trial but have taken a break from recruiting, have a line up of potential patients waiting to get in this trial but couldn't as a result of the spaces potentially being needed for FDA purposes. Once the FDA requirements are known the remaining 300 recruits will happen faster than at any point so far in this trials history. Because recruits must have had an event between 5 and 90 days ago there could be a line up of many many potential recruits from every clinic that would then be in the trial. My guess is 30 to 45 days and the trial would be fully recruited.
The SSA is then completed. Once the trial is fully recruited would anything really be gained by winding it up sooner because of great efficacy numbers with less than 15% of the remaining patients dosed left to complete their course of drug to complete the trial. We get primary readout prior to end of Q4. Trial is completed, safety data in hand, assuming it is positive and we get the much needed EMA and possibly FDA approval.
Still speculating, what if there is a deal for ZEN3694 to be bought out for say, $2 to $3 billion. Wouldn't that be a nice time to do a Wrights offering for the current RVX shareholders whom many just happen to have flush pockets from their ZEL windfall.
Speculation is so much fun sometimes. Looking forward to hearing what both companies have to say next week.
Go ahead, beat me up just for fun.
All just speculation. DYODD
tada