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Posted On: 11/24/2021 9:20:04 AM
Post# of 148899
And it was worth only 350mg. I wonder if 700mg will be more efficacious.
On a separate topic, would someone please explain (again) what has to happen after the BLA is filed that allows commercial sales of LL? Is it simply the acceptance by the EFFDA? Like they respond to the Company that they have accepted the BLA and that's it? Or did the EFFFA has to give formal notice that the Company is allowed to do commercial sales?
Going back to NASH, sounds like it should be an easy approval for BTD and with the excellent safety profile of LL. Not sure how different BLA for NASH would be from the BLA for HIV, but given that the Company has so much experience in how NOT to for a BLA, it might be that LL becomes available for both diseases at the same time (with a phase 3 trial for NASH to complete the paperwork).
On a separate topic, would someone please explain (again) what has to happen after the BLA is filed that allows commercial sales of LL? Is it simply the acceptance by the EFFDA? Like they respond to the Company that they have accepted the BLA and that's it? Or did the EFFFA has to give formal notice that the Company is allowed to do commercial sales?
Going back to NASH, sounds like it should be an easy approval for BTD and with the excellent safety profile of LL. Not sure how different BLA for NASH would be from the BLA for HIV, but given that the Company has so much experience in how NOT to for a BLA, it might be that LL becomes available for both diseases at the same time (with a phase 3 trial for NASH to complete the paperwork).
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