Saturday, April 17, 2021 4:56:38 PM
Some thoughts on Mitigate
1) first posted on clinicaltrials.gov site on August 10th
2) an interim analysis will be performed after 50% of patients (750 pts) have been enrolled and accrued a minimum follow-up duration of 3 months
3) As of Dec 12th, they had enrolled about 500 pts (per Bhatt at NLA presentation)
4) Assume minimal enrollment in first month that they get the trial up and running and that the recruitment rate increases with time
5) they essentially enrolled 500 pts in 3 months, so about 150 pts/month (and increasing)
6) they needed 250 more pts to hit the interim analysis point - so about 6 weeks (or less)
7) that rate would put them at 750 pts by the end of January
8) add 3 months for minimum follow-up and you get the end of April
9) quickly put the data together and maybe they could have something to present May 15th at ACC 2021
Bottom line: reasonable expectation to hear interim analysis data by mid-May and ACC would be the ideal place to announce positive results for a cardiovascular drug to treat COVID.
Disclaimer: I have absolutely no experience with how long it takes from accessing interim data to having something to present. I doubt they will have time to apply to ACC for a poster presentation or organize a “late breaking clinical trials” spot but a simple news PR buy Kaiser at the event would do just fine.
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