Cytodyn Inc (CYDY)

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Take the 4 doses that FDA denied and ANVISA approved. ANVISA did not do this just because all of a sudden, safety was proven in cd12 by the standards of clinical trials (does FDA agree that safety is established?). Rather it is acknowledgment that cd12 data suggests the possibility that 4 doses can be particularly relevant and that unlike FDA, ANVISA did not think it necessary or proper to reduce 4 to 2 when the Cytodyn team asked for it pointing out our past data including cd12. cd12 had something to do with ANVISA thinking 4 doses should be allowed. Of course it is not an endorsement of the drug; it is an endorsement of the phase 3 trial protocol that it is consistent with the data and evidence coming out of past trials - in this case that we are justified in seeking to test critical and oxygen requiring severe patients with four doses of our drug.

What do you mean "manipulation of statistics"? They are not barred from giving you an analysis and interpretation of data that they think is significant to explain the overall results. If they think age may have mattered, then they are making that point - are they the first company to do an age-adjusted assessment of the data? Who said this is necessarily improper to put in an 8-k on trial results?

Definitely, cd10 NEWS data involved misrepresentation of some kind since the company said it was a secondary endpoint that succeeded but never countered the FDA letter that said no secondary endpoint was met. They may not have wanted to show opposition to FDA but it left a bad taste. I give you that. But that does not transfer over to cd12 and its critical subgroup. You can distrust them for that cd10 statement, but it is not a proof here and I don't club it all together.

And with cd12, I do see the words "statistically significant" in the 8-k for three things: mortality benefit for LL+commonSOC over common SOC (p=0.0319), mortality benefit for LL+Dex over Dexamethasone (p=0.0552), and the Time to Discharge for Critical patients (p=0.005). This is on pages 19, 21, 23. SS is not given for the Dex result here but is tagged in page 7 for the same.

The first two are determined based on the Logit model whereas the Discharge analysis is based on Rank-ANCOVA model. Let's assume Cytodyn was honest about it this far.

Its interesting how the FDA addresses SS in their letter.

FDA: the data from CD12 illustrated imbalances in mortality among subgroups, some favoring leronlimab and some favoring placebo. None of these analyses met statistical significance when using established and reliable analytical methods that correct for multiple comparisons.

FDA rejects the claim of SS in mortality for the two subgroups, which essentially would mean they reject our using the Logit model for this purpose. However their letter does not address whether Cytodyn was correct in claiming SS for Time-to-Discharge in the smaller critical subgroup. And Cytodyn itself was mostly emphasizing SS for Time-to-Discharge (and not for the overall subgroup mortality) to its investors. The other thing Cytodyn emphasized of course is the 14-day mortality benefit for the Critical subgroup alone, though they did not state it as being SS.

So, yes the company can be accused of misrepresenting SS in the two mortality subgroups if they knew the FDA does not accept that model and will not classify the result as SS even if the same was true for the whole population.

What however matters to me is whether the Company misrepresented the SS claim regarding Time-to-Discharge and the mortality data for the Critical-subgroup. That is what Cytodyn actually touted as a compelling case to its shareholders. FDA is playing a subgroup game with the different things Cytodyn said, emphasizing what we ourselves skimmed over and skipping or dismissing 'cleverly' what we are actually emphasizing.

They are silent about the third SS-claim that was based on a different model, and they slide over the mortality data in the critical group by dissing the small sample size and by conflating it with the talk on SS for the other subgroups. So the reader deals with a mixed bag in a short paragraph and misses the main things that Cytodyn wants to highlight.

What pertains to the Time-discharge and Critical-group mortality cannot be dismissed or undermined by conflating its discussion with what Cytodyn said or mis-said about the general groups. FDA does exactly this which is why we can't take their letter too seriously. ANVISA also did not!!!