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Posted On: 04/17/2021 5:19:17 PM
Post# of 148878
(Thanks Kevin for posting the Philippine Leron clarification. https://www.fda.gov.ph/clarification-on-the-a...eronlimab/)
This sentence is what got my attention:
'A CSP can only be requested by physicians in charge or by the institution . . . who takes full responsibility for the use and dispensing of the requested drug product. The CSP holder must . . . provide a report to the FDA of the outcomes for every patient given the product.'
The mention of physician 'responsibility' sounds similar to what Philippine FDA chief Eric Domingo discussed during a video that was recently posted. (Dang--can't find it again to include it. Believe it was Cito Beltran with Eric Domingo.) During that video Cito repeatedly asks Domingo about this 'responsibility' put upon the doctors. Domingo seems to respond with the notion that that is the way it goes with treatments still in trials until EAU or approval.
IMO - this puts the docs and medical systems in a bad situation. My appreciation and respect for those docs treating the 28 patients is enormous. They might be risking a lot more than a month not posting on a message board. Leron will eventually prove itself and break out - but this is a large hurdle- again IMO.
This sentence is what got my attention:
'A CSP can only be requested by physicians in charge or by the institution . . . who takes full responsibility for the use and dispensing of the requested drug product. The CSP holder must . . . provide a report to the FDA of the outcomes for every patient given the product.'
The mention of physician 'responsibility' sounds similar to what Philippine FDA chief Eric Domingo discussed during a video that was recently posted. (Dang--can't find it again to include it. Believe it was Cito Beltran with Eric Domingo.) During that video Cito repeatedly asks Domingo about this 'responsibility' put upon the doctors. Domingo seems to respond with the notion that that is the way it goes with treatments still in trials until EAU or approval.
IMO - this puts the docs and medical systems in a bad situation. My appreciation and respect for those docs treating the 28 patients is enormous. They might be risking a lot more than a month not posting on a message board. Leron will eventually prove itself and break out - but this is a large hurdle- again IMO.
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