Ann: COVID-19/GVHD Update, Quarterly Report and Appendix 4C, page-161

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Tunnah

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30/07/20

21:27

Post #: 46198076
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Originally posted by LeftYahoo: ↑

I find the most intriguing statement in the quarterly update to be the following:

"Up to 30 leading medical centers across the United States are expected to participate in the trial, which is expected to complete recruitment in September 2020"

In essence it means May, June, and July were devoted to recruiting/enrolling the first 90 patients, while August and September will see the final 210 enrolled. Suggesting recruitment in the early months was deliberately slow and is being ramped up quickly in later months.

I guess I'm a bit surprised by the short span of time between interim review by the DSMB and full recruitment of the trial.... given that a principal reason for the interim review is to avoid dosing patients - with either product or placebo - when it is inutile or unsafe to do so. It suggests at least for the safety part there isn't much concern there, and full throttle recruitment is ongoing while the last of the initial 90 complete 30 days of observation.

This is labelled a phase 2/3 trial, so perhaps early recruitment was slow-paced out of an abundance of safety precaution... However, Mesoblast had already done the EAP so that doesn't explain everything. It does take time to get new centers up to speed on recruiting, all of the EAP cases were done at just one center.... But I'm not sure that explains everything either given the Calibre if the trial sites and the fact they've previously worked together in an established network.

I continue to believe that management had mapped out a full strategy back in February/March when the decision was made to steer the company towards a treatment for C-19, including the challenge of manufacturing potentially hundreds of thousands of doses and marketing/distributing to all of the ICUs in the US, Australia, and eventually the world. So slower recruitment in May and June would allow other trial centers to get up to speed, yes. And more importantly it would also buy time to get partnership negotiations underway/agreements in place. I don't think management would risk a DSMB interim review - and the potential for FDA approval or an EUA - without having full preparation in the wings to deal with a massive product roll out. As those partnerships shape up recruitment can speed up, perhaps the most important message buried in today's quarterly announcement.

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Yeah I think potential slow down could have also been due to the improvement in New York infection rates also since May. Since Mt Sinai is the main contact centre and the efficacy for continuation was made from there during Phase 2, I would have thought they would want most of the patients to come from there (also from a logistics standpoint). In the second round of hospital funding figures which were posted, only one of Icahns new york locations received funding for having "over 161 covid-19 patients"

Last edited by Tunnah: 30/07/20

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Ann: COVID-19/GVHD Update, Quarterly Report and Appendix 4C, page-161

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