All this talk of how biased, corrupt and/or ineffi
Post# of 155133
(Total Views: 622)
Posted On: 11/03/2023 9:46:36 AM
All this talk of how biased, corrupt and/or inefficient the FDA is is kind of pointless. Cytodyn is not going to fix any of that and it will not change. If we feel the ability for leronlimab to be a success is based on navigating this then the history of small biotechs that fail says a lot.
Other small biotechs don't have leronlimab. lets remember this drug does not just have a few studies showing its potential. it has phase 2 and 3 FDA protocol trials showing that it does alot in alot of indications.
lets put the 2 together - you don't get approvals unless you are a big pharma and leronlimab has already shown in FDA trials that it can generate billions of revenue in many indications. If you are in the MA department of any big pharma in the world, this is a slam dunk. think about it, a BP can buy this and in less than a year finish off the HIV BLA and generate billions.
Cytodyn has stated all future trials will be with a partner, not just because they don't have the funding to pay for it on their own, but because they know the FDA basically requires a BP to make things happen. It is impossible to imagine how the BOD figures out how to take one opportunity without possibly missing out on the value of another. If this was a one indication drug it would be easy.
maybe nothing is going on over at cytodyn HQ, but i find it hard to believe that once the hold is lifted that deals won't be popping up all over the place.
Other small biotechs don't have leronlimab. lets remember this drug does not just have a few studies showing its potential. it has phase 2 and 3 FDA protocol trials showing that it does alot in alot of indications.
lets put the 2 together - you don't get approvals unless you are a big pharma and leronlimab has already shown in FDA trials that it can generate billions of revenue in many indications. If you are in the MA department of any big pharma in the world, this is a slam dunk. think about it, a BP can buy this and in less than a year finish off the HIV BLA and generate billions.
Cytodyn has stated all future trials will be with a partner, not just because they don't have the funding to pay for it on their own, but because they know the FDA basically requires a BP to make things happen. It is impossible to imagine how the BOD figures out how to take one opportunity without possibly missing out on the value of another. If this was a one indication drug it would be easy.
maybe nothing is going on over at cytodyn HQ, but i find it hard to believe that once the hold is lifted that deals won't be popping up all over the place.
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