Let me first state that I am not in the medical field.
I understand what you are saying and in theory agree, but in reality an approval for any indication will improve and speed the outcome of any additional indication/s. As you noted, simply due to the safety and CMC portions. Not only because the trial burden is significantly less or eliminated in the case of the CMC, but those two portions are already vetted and approved also reduces FDA review and approval time with a supplemental BLA (sBLA).
Secondly, if leronlimab was already approved for say combo HIV, trial enrollment would likely be much faster.....and this doesn’t even include if it was mentioned by name on National media by the President and Dr. Fauci for two months straight. HCQ and remdesivir have been tested in thousands of patients already......if leronlimab was tested on 200 with similar results as they have shown in the early data released they would be approved by now if they had another indication already approved IMO.....not to mention ramp up of manufacturing with a prior approval would likely not be as big of hurdle either.
Yes, clinical safety and efficacy are needed for each indication, but having an approval adds a lot of credibility and would lower or reduce many obstacles we are currently facing with CV-19. JMO and looking forward to more positive data.....after all no longs were in this for CV-19, and HIV, cancer and many other indications (hopefully) are still advancing nicely. Best of luck!
I understand what you are saying and in theory agree, but in reality an approval for any indication will improve and speed the outcome of any additional indication/s. As you noted, simply due to the safety and CMC portions. Not only because the trial burden is significantly less or eliminated in the case of the CMC, but those two portions are already vetted and approved also reduces FDA review and approval time with a supplemental BLA (sBLA).
Secondly, if leronlimab was already approved for say combo HIV, trial enrollment would likely be much faster.....and this doesn’t even include if it was mentioned by name on National media by the President and Dr. Fauci for two months straight. HCQ and remdesivir have been tested in thousands of patients already......if leronlimab was tested on 200 with similar results as they have shown in the early data released they would be approved by now if they had another indication already approved IMO.....not to mention ramp up of manufacturing with a prior approval would likely not be as big of hurdle either.
Yes, clinical safety and efficacy are needed for each indication, but having an approval adds a lot of credibility and would lower or reduce many obstacles we are currently facing with CV-19. JMO and looking forward to more positive data.....after all no longs were in this for CV-19, and HIV, cancer and many other indications (hopefully) are still advancing nicely. Best of luck!
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