Just to fill you in your really need to read that article
https://insiderfinancial.com/cytodyn-cydy-sho...le/181861/
This is what you missed - the FDA never said that - The Oregonian made it up.
This article takes everything the company said in its 10-K filing about the SEC investigation out of context to create the illusion that there is a massive investigation starting right now over its claims of efficacy. In retrospect, the SEC looks like it has moved on and completed their probe. So while this snippet of news is “newly filed” it’s really about the company reporting old news at best. In this new article The Oregonian recycled part of their old article from May 18th, 2021 when it claimed the FDA found “no clinical benefit” from the drug. So along with the announcement of an investigation that is likely already closed it is attempting to paint a picture that the drug didn’t work according to the FDA statement about leronlimab. The Oregonian alleged the FDA said
“data the company had published that purported to show a small benefit from leronlimab as a COVID-19 treatment were statistically insignificant, and that trials had found “no clinical benefit.”
The source for this was a conclusion drawn by another author at The Oregonian not the FDA. The FDA never said any of these things and quite frankly readers should demand a retraction. Here is what the FDA actually said.
“the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19.”
Readers need to parse the qualifying statement in the first part of the sentence which says “the data currently available.” The facts show at the time of this statement the FDA had not reviewed the 14 day mortality data which showed an 82% reduction in 14 day mortality. Notice the FDA is never quoted as saying “no clinical benefit.” It is a fabricated quote and a conclusion taken out of context.
Regarding The Oregonian claims that the FDA said leronlimab was statistically insignificant. Here is what the FDA actually said in context, not the fabrication presented by The Oregonian.
“None of these analyses met statistical significance when using established and reliable analytical methods that correct for multiple comparisons. However, as noted above, such analyses may inform the design of future clinical trials investigating leronlimab for the treatment of COVID-19.”
The FDA again qualifies their statement sticking to “none of these analyses” which means nothing that they looked at yet. Their reference to “reliable analytical methods that correct for multiple comparisons” refers to subgroup analysis that should have been specified in the protocol before it was started. The FDA takes serious issue with trial results that were not pre specified. They will not rely on subgroup analysis but they do say at the end that “such analyses may inform the design of future clinical trials.” This is the equivalent of the FDA asking for more data.
https://insiderfinancial.com/cytodyn-cydy-sho...le/181861/
This is what you missed - the FDA never said that - The Oregonian made it up.
This article takes everything the company said in its 10-K filing about the SEC investigation out of context to create the illusion that there is a massive investigation starting right now over its claims of efficacy. In retrospect, the SEC looks like it has moved on and completed their probe. So while this snippet of news is “newly filed” it’s really about the company reporting old news at best. In this new article The Oregonian recycled part of their old article from May 18th, 2021 when it claimed the FDA found “no clinical benefit” from the drug. So along with the announcement of an investigation that is likely already closed it is attempting to paint a picture that the drug didn’t work according to the FDA statement about leronlimab. The Oregonian alleged the FDA said
“data the company had published that purported to show a small benefit from leronlimab as a COVID-19 treatment were statistically insignificant, and that trials had found “no clinical benefit.”
The source for this was a conclusion drawn by another author at The Oregonian not the FDA. The FDA never said any of these things and quite frankly readers should demand a retraction. Here is what the FDA actually said.
“the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19.”
Readers need to parse the qualifying statement in the first part of the sentence which says “the data currently available.” The facts show at the time of this statement the FDA had not reviewed the 14 day mortality data which showed an 82% reduction in 14 day mortality. Notice the FDA is never quoted as saying “no clinical benefit.” It is a fabricated quote and a conclusion taken out of context.
Regarding The Oregonian claims that the FDA said leronlimab was statistically insignificant. Here is what the FDA actually said in context, not the fabrication presented by The Oregonian.
“None of these analyses met statistical significance when using established and reliable analytical methods that correct for multiple comparisons. However, as noted above, such analyses may inform the design of future clinical trials investigating leronlimab for the treatment of COVID-19.”
The FDA again qualifies their statement sticking to “none of these analyses” which means nothing that they looked at yet. Their reference to “reliable analytical methods that correct for multiple comparisons” refers to subgroup analysis that should have been specified in the protocol before it was started. The FDA takes serious issue with trial results that were not pre specified. They will not rely on subgroup analysis but they do say at the end that “such analyses may inform the design of future clinical trials.” This is the equivalent of the FDA asking for more data.
6
