Wow fantastic Webcast !!There was a great question regarding...

Wow fantastic Webcast !!

There was a great question regarding powered significance in the Trial Design for 300 patient COVID ARDS Rem-L Trial.

SI commented that they have been conservative in the trial assumptions for control group mortality which is much lower than current rate mortality for medium-severe ARDS due to COVID of between 60%-80% so if the results of using Rem-L in these patients are in line with Mt Sinai Hospital EAP then we would need only a fraction of the 300 patients to be statistically powered in achieving primary endpoint!

Bloody fantastic.

Also, he talked to extension of Rem-L for the 160,000 yearly US patients suffering from viral ARDS such as pneumonia. So extending label for Rem-L to viral ARDS.

Further, upon approval from FDA, MSB will partner for manufacturing for the US market and scale up production.

IMO, they will have significant US govt fiscal support to scale up with their manufacturing partners once FDA approve!

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