Ann: Remestemcel-L FDA Fast Track Designation for COVID-19 ARDS, page-498

Some thoughts from the US Yahoo board last night re Covid ARDS trial re timing on outcomes:

LongStock9 hours ago

Mesoblast announced the filling of 180 patients in the Covid-19 ARDS trial on November 19, 2020. This means that the 30 day patient collection date is around December 19, 2020. Its been taking the trial DSCB about two weeks to assimulate the data and about 1 week for Mesoblast to reveal the DSCB decision. But, this time it may be a little different because Novartis is now in mix and they will have to be in the news loop too.

I don't see any trial news being released before the second week of January 2021. And, with data being already collected for 180 patients there is a possibilty the control board may designate the "overwhelming" option to this trial and declare the product fully efficacious and ready for the approval application. We'll soon see about that.

Since Mesoblast is so close to filling the trial with all 300 patients they may just elect to go ahead and finish the trial anyway.

London8 hours ago

From memory, the announcement was worded cleverly so we actually don't know when the 180th patient was treated. In the 10 November 2020 announcement it was also worded vaguely that the third interim analysis would occur "in the coming weeks".

IMO, I think that the 180th patient may have been treated in early to mid November, and that technically we could be hearing from the DSMB in mid-December. This correlates with what Bell Potter brokers have been saying, and they have been on the mark for the date of the interim analysis' 1 and 2 reveals...

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  Left-e6 hours ago

  @london, I agree. The reference to 180 patients enrolled was made in a bullet point on slide 16 at the AGM (November 24, 2020), “Enrollment has now passed 180 patients”. So, in preparation for the AGM it sounds like the company checked in with the trial coordinators for a status report. They were told, “we're over 180” but the exact date of that occurrence could have been several days to a week or two earlier. Note also that enrollment is ongoing beyond the 180 with full 300 patient enrollment expected sometime in Q1. That's been pushed back from “by end of the year”. Offsetting that push back is the uptick in cases which should speed enrollment. An additional 120 patients will be coming into the study to reach the full 300 patient goal. 60 more rem-L and 60 placebo. It means by the time the DSMB performs its 3rd interim check, the study could be approaching full enrollment, and the committee will certainly take a peek at mortality data on those newly enrolled even if under 30 days. If the study is indeed showing significant rem-L efficacy, the primary job of the committee is to protect the placebo patients, most especially the newly enrolled ones where a life and death drama is still playing out. To give them a chance to cross over early and avoid the fate of preceding placebo receivers. And that extends to an ethical obligation to protect ICU patients with C-19 not enrolled in the study. Those are “placebo” patients too, since they receive standard of care without rem-L. And hundreds are dying every day, though Longstock's comment is well taken. A continuation of the study is not bad news, but there will be max pressure on the DSMB this time, imo.