You call that thinking big picture, craigakess? (
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Posted On: 10/14/2020 6:37:34 PM
Re: craigakess #61161
You call that thinking big picture, craigakess? (Not trying to be too sarcastic.)
Let me give it a shot!
Let's say Leronlimab kicks ass again in the interrum review by the DSMB, as we expect it will. If I understand the process for the handling of the review results, only the DSMB and the FDA will have full access to the DSMB's evaluation of the data. The ball is then handed to the FDA to make the determination of what to do with that data and the fate of the trial (and EUA).
I don't believe the FDA is required to tell Cytodyn anything about the data or trial right away except to tell them that the review is done. Cytodyn can force a revealing of the review but at a cost. The FDA, doesn't have to reveal what they are going to do with the data or the trial for probably a limited number of days, perhaps even 60 days, which seems to be a favorite timescale for them.
But in times like these, I expect they will move faster. Still, and here is the interesting part, because these are not normal times and because of the results I believe Leronlimab will deliver, the FDA may be set back on their heels for a while.
What would you do if you finally had, in your hands, the hard evidence that Cytodyn had found the Holy Grail?
That would be the FDA's dilemma. Do you think their first instinct would be to call Cytodyn and tell them? I don't think so. And then let them tell us?
First, they would tell all the mucky-mucks higher up on the ladder and pass the info up to them. Those mucky-mucks would have to make some decisions about what to do next. (I can only imagine!) They will want to know how much Leronlimab is available before they make any decision on an EUA, if nothing else.
They would probably start some intense talks with Cytodyn about a bunch of things but would want Cytodyn to keep AS SILENT AS POSSIBLE until the FDA is clear about Cytodyn's capabilities and the FDA's own responsibilities in handling such a "hot potato."
Leronlimab is exactly the treatment that the huge trial study, announce JUST YESTERDAY by the NIH and Fauci's National Institute of Allergy and Infectious Diseases (NIAID), hoped to find! As I posted yesterday, it blows my mind, that at this late date, they are still desperately trying to find, yet again, anything that can do something against Covid-19 what Leronlimab already does!
I suspect that Cytodyn will probably find out something about the DSMB results this week but I don't expect we will be told much of anything. The news will be just too HOT! Many ducks will have to be put in a row before we will be told anything!
By the way, Pourhassen said at the Shareholder's meeting that the first batch of Leronlimab from Samsung was due for delivery about today. I hope it is in vials. That would be news to celebrate!
Let me give it a shot!
Let's say Leronlimab kicks ass again in the interrum review by the DSMB, as we expect it will. If I understand the process for the handling of the review results, only the DSMB and the FDA will have full access to the DSMB's evaluation of the data. The ball is then handed to the FDA to make the determination of what to do with that data and the fate of the trial (and EUA).
I don't believe the FDA is required to tell Cytodyn anything about the data or trial right away except to tell them that the review is done. Cytodyn can force a revealing of the review but at a cost. The FDA, doesn't have to reveal what they are going to do with the data or the trial for probably a limited number of days, perhaps even 60 days, which seems to be a favorite timescale for them.
But in times like these, I expect they will move faster. Still, and here is the interesting part, because these are not normal times and because of the results I believe Leronlimab will deliver, the FDA may be set back on their heels for a while.
What would you do if you finally had, in your hands, the hard evidence that Cytodyn had found the Holy Grail?
That would be the FDA's dilemma. Do you think their first instinct would be to call Cytodyn and tell them? I don't think so. And then let them tell us?
First, they would tell all the mucky-mucks higher up on the ladder and pass the info up to them. Those mucky-mucks would have to make some decisions about what to do next. (I can only imagine!) They will want to know how much Leronlimab is available before they make any decision on an EUA, if nothing else.
They would probably start some intense talks with Cytodyn about a bunch of things but would want Cytodyn to keep AS SILENT AS POSSIBLE until the FDA is clear about Cytodyn's capabilities and the FDA's own responsibilities in handling such a "hot potato."
Leronlimab is exactly the treatment that the huge trial study, announce JUST YESTERDAY by the NIH and Fauci's National Institute of Allergy and Infectious Diseases (NIAID), hoped to find! As I posted yesterday, it blows my mind, that at this late date, they are still desperately trying to find, yet again, anything that can do something against Covid-19 what Leronlimab already does!
I suspect that Cytodyn will probably find out something about the DSMB results this week but I don't expect we will be told much of anything. The news will be just too HOT! Many ducks will have to be put in a row before we will be told anything!
By the way, Pourhassen said at the Shareholder's meeting that the first batch of Leronlimab from Samsung was due for delivery about today. I hope it is in vials. That would be news to celebrate!
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