product on hand is expiring - right... so the clin
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(Total Views: 514)
Posted On: 08/16/2022 10:14:39 AM
Re: HouseofCards #127686
product on hand is expiring - right... so the clinical hold, which according to some, should be lifted any day now. and according to others, clinical hold could last a lot longer.
my understanding is - in the process of gaining approval or EUA for any drug, there needs to be a solid production pipeline in place to meet demand. makes sense. but it also means having ready to market product also. which means if there is any hiccup in the EUA/approval process, the product will sit for some time, risking expiration and massive waste and write off.
hmmmm.... could be one of the short mafias' tools to hurt such companies? and the FDA has no hand in this destructive effort?
meanwhile a couple hundred are dying of covid everyday, not a peep on the news about this. 1,030,000 as of today. thats 30,000 since may 17 when the million mark was officially announced. yep we have been officially de-sensitized completely.
this extremely expensive and wasteful for us, what about the actual patients? the drug clearly has shown exceptional benefit to so many in the HIV an covid space, yet the authorities decided that cytodyn needs to be taken down multiple notches, and needs to play ball by their set of rules. i will use my analogy again of the titanic sinking and no one can use the lifeboats because they were painted this morning and the paint isnt dry yet. completely absurd.
the NASH data will eventually be so overwhelming that it cant be ignored or blocked. the NDAs and how they have been referred to have given us the signal that a deal/partnership is almost a done deal. most BPs are shopping for their next blockbuster, and we are sitting on a fat one.
my understanding is - in the process of gaining approval or EUA for any drug, there needs to be a solid production pipeline in place to meet demand. makes sense. but it also means having ready to market product also. which means if there is any hiccup in the EUA/approval process, the product will sit for some time, risking expiration and massive waste and write off.
hmmmm.... could be one of the short mafias' tools to hurt such companies? and the FDA has no hand in this destructive effort?
meanwhile a couple hundred are dying of covid everyday, not a peep on the news about this. 1,030,000 as of today. thats 30,000 since may 17 when the million mark was officially announced. yep we have been officially de-sensitized completely.
this extremely expensive and wasteful for us, what about the actual patients? the drug clearly has shown exceptional benefit to so many in the HIV an covid space, yet the authorities decided that cytodyn needs to be taken down multiple notches, and needs to play ball by their set of rules. i will use my analogy again of the titanic sinking and no one can use the lifeboats because they were painted this morning and the paint isnt dry yet. completely absurd.
the NASH data will eventually be so overwhelming that it cant be ignored or blocked. the NDAs and how they have been referred to have given us the signal that a deal/partnership is almost a done deal. most BPs are shopping for their next blockbuster, and we are sitting on a fat one.
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