Easiest and cheapest way to validate leronlimab ex
Post# of 148187
(Total Views: 725)
Posted On: 10/11/2020 10:03:25 AM
Re: ClosetInvestor #60727
Easiest and cheapest way to validate leronlimab ex-HIV would have been the GvHD study, with an interim analysis of 10 patients after 30 days, and an easy path to approval if the results of the mice studies (100% survival) were replicated... Sites already identified and ready to go, a pity that only 1 patient enrolled under amended protocol and that this has been dragging for years now...
"The modified protocol now includes reduced intensity conditioning (RIC) patients and an open-label design under which all enrollees receive leronlimab. The modified protocol also provides for a 50% increase in the dose of leronlimab to more closely mimic preclinical dosing. The next review of data by the independent data monitoring committee (iDMC) will occur following enrollment of 10 patients under the amended protocol after each patient has been dosed for 30 days."
"The modified protocol now includes reduced intensity conditioning (RIC) patients and an open-label design under which all enrollees receive leronlimab. The modified protocol also provides for a 50% increase in the dose of leronlimab to more closely mimic preclinical dosing. The next review of data by the independent data monitoring committee (iDMC) will occur following enrollment of 10 patients under the amended protocol after each patient has been dosed for 30 days."
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