Pressure’s building; I can feel the nerves and tension in the posts. I expect there to be a continuation of articles about MSB but with little new news; the upcoming talk fest next week may deliver another confidence nugget but I figure there is another couple of weeks to endure before the KARBOOM.
I initially thought that some early news of MSB’s covid-19 ARDS trial would just have to have filtered/leaked by now, but giving more thought to the construct of the trial, I now believe this is unlikely.
The trial involves 300 patients across some 30 or more centres; so on average 10 patients per centre (5 on treatment and 5 on placebo). I also understand that there may be other patients as part of other treatment trial(s) at these centres. Besides the secrecy of the dispensing of trial treatments, the doctors and nurses etc. at these centres are busy, and would be unlikely to deduce, from a low patient cohort and the various trials taking place, the real effectiveness of any treatment.
The first patient(s) dosed on Wednesday May 6th.
Friday June 5th marks the trial’s first 30 day primary end point and is significant in that it is the start of the Queen’s Birthday long weekend.
90 patients (30%) may not have been dosed on May 6th ,but there is the possibility that a significant number were when one considers that the Mount Sinai Hospital and its affiliated hospitals had a head start in trial recruitment from the early closure of the EAP; and ‘dosed’ could mean ‘fully dosed’ meaning patients are already 4-5 days into the trial. Either way, the trial administrator would be starting to gather a growing number of patient primary end point data (30 day) from June 5th
The interest in this trial can’t be understated – there will no doubt be a lot of people that will want to know, and be the first to know;.… and someone always talks. I DON’T KNOW, but I wouldn’t be surprised if there wasn’t some sort of leak prior to the first official trial progress announcement, which would most likely be preceded by a trading halt.
This train is moving and I DON’T KNOW, June 5th maybe THE get on/get off- by date depending on your outlook.Intending passengers need to have buckled up; the brochure looks exciting.
Range of initial trial result outcomes
Best case for MSB is for 45 treated patients to survive and survive quickly whilst 45 placebo patients remain on ventilation, or dare I say, die. As the selected trial patients were not the worst of the worse cases as per the EAP, patient deaths should (one would hope) not figure prominently, but a prolonged time on ventilation is far from ideal.
Worst case for MSB is the death of a treated patient, and in particular, more deaths than that of the placebo group.
I think the secondary end point measure (the number of days alive off ventilator support ) will prove to be significant.
(20min delay)