Others are better qualified to answer, but I will
Post# of 155038
(Total Views: 397)
Posted On: 09/17/2019 12:03:04 PM
Re: ClosetInvestor #8236
Others are better qualified to answer, but I will comment based on previous discussions.
Trding and misiu previously discussed this from opposite perspectives. Trding stated that all HIV mono drugs had at least 48-weeks trials, so my guess is the FDA is keeping the same standard for leronlimab as other mono drugs.
I agree with you that we have a lot more data than many other drugs and seems like the FDA could 'work with us a little' if they were 'adamant' of getting mono approved. I know the FDA needs to ensure meds are safe and effective before approval, so sorry for venting frustration with their actions and barely conceding anything for such an amazing drug.
Many times in a football or basketball game if the official makes a bad call they will either have a make-up call shortly after or be more lenient of the next infraction. I feel like leronlimab is the New Orleans Saints playing the Los Angeles Rams!
Trding and misiu previously discussed this from opposite perspectives. Trding stated that all HIV mono drugs had at least 48-weeks trials, so my guess is the FDA is keeping the same standard for leronlimab as other mono drugs.
I agree with you that we have a lot more data than many other drugs and seems like the FDA could 'work with us a little' if they were 'adamant' of getting mono approved. I know the FDA needs to ensure meds are safe and effective before approval, so sorry for venting frustration with their actions and barely conceding anything for such an amazing drug.
Many times in a football or basketball game if the official makes a bad call they will either have a make-up call shortly after or be more lenient of the next infraction. I feel like leronlimab is the New Orleans Saints playing the Los Angeles Rams!
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