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***OFFICIAL CYDY/Leronlimab Thread***


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Yes, go ahead FC42

I closed.  Cydy operation mountain house completed.

Told my wife I was about to buy some more and she said that’s what I’ll get to keep in the divorce proceedings 😂😂😭😭😤

Sometimes having faith in this stock is akin to believing the Easter Bunny is going to come to visit in a month's time.

I don't think they hit their primary endpoint, I'll just leave it at that.  Doesn't mean game over but that's where the holdup is if you ask me. 

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From Ihub regarding endpoints.  FDA apparently changed guidelines 4 days ago...

Quote

FDA Changes EndPoint Guidelines for Severe/Critically Ill COVID Therapeutics/Biologics on Feb 22, 2021

I found this information interesting and possible explanation of why Cytodyn did not release TLD and why they are talking with the FDA. However, make your opinion on these findings.


FDA Guidelines (sources)

May 11, 2020 guidelines:
https://issuu.com/greeley2/docs/fda_guidancecovid_19-developing-drugs


Feb 22, 2021:
Press release: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-policies-guide-medical-product-developers-addressing-virus

Updated Guidelines: https://www.fda.gov/media/137926/download[/url][tag]insert-text-here

Comparison
Quote:
- In a trial in severe and/or critically ill patients, examples of
appropriate endpoints could be
- All-cause mortality at an appropriate time point
(e.g., at least 28 days for hospitalized noncritically ill
patients,(footnote27) 60 days for critically ill
patients(footnote 28)

- Footnote 28
"C Karagiannidis, C Mostert, C Hentschker, T Voshaar, J Malzahn, G Schillinger, J Klauber, U Janssens, G Marx,
S Weber-Carstens, S Kluge, M Pfeifer, L Grabenhenrich, T Welte, and R Busse, 2020, Case Characteristics,
Resource Use, and Outcomes of 10021 Patients with COVID-19 Admitted to 920 German Hospitals: an
Observational Study, Lancet Respir Med, 8(9):853–862."

(This study seemed to influence the change)

The FDA has changed the guidance for endpoints related to Critically Ill Covid Patience on All-Cause Mortality from 28 days (May 11,2020) to 60 days (Feb 22, 2021).

Is it a coincidence that Nader issues a press release the same day the FDA updated guidance? I think this was intentional.

With this new guidance the CYDY CD12 Trial is in a gray area. The trial is concluded with data at 14 days, 28 days and 42 days (reco from DSMC). However, the FDA is reco/asking for 60 days of data for Critically Ill. I doubt that the FDA revised this guidance on Feb 19th and probably was pulling this together over the past month, the same time CYDY was ready to report.

Either CYDY was aware of these changes in early FEB (after Nader said TLD was going to be reported) OR FDA contacted CYTO to let them know (less likely) or CYDY went to share the unblinded data with the FDA first and they realized they had an conflict between the data collected and the new guidelines being developed. Maybe the FDA needed some time to provide guidance to CYDY on how to manage the data from the trial and path for submission.

This quote (IMO) makes a little more sense now. “We are eager to reach conclusion in our discussions with all the regulatory agencies for the path going forward and will release the details of our data and the results of our discussions with regulatory agencies in the coming weeks.”

You make your own decision, but did not see anyone talking about this point.

 

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They could be looking at 42-day and 60-day data.  With ventilators and ECMO, many placebo patients could live to 28-days and then pass away a week or two later.  Makes sense to me. 

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20 minutes ago, chet said:

They could be looking at 42-day and 60-day data.  With ventilators and ECMO, many placebo patients could live to 28-days and then pass away a week or two later.  Makes sense to me. 

This makes the most sense but I have a dumb question.  The OLE basically moved all the placebo patients on to LL, correct?  When was that done?  Presumably prior to 60 days.  Wouldn't that make an analysis of 60 day endpoint impossible and necessitate a new study?  I hope I am wrong.

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6 minutes ago, unckeyherb said:

This makes the most sense but I have a dumb question.  The OLE basically moved all the placebo patients on to LL, correct?  When was that done?  Presumably prior to 60 days.  Wouldn't that make an analysis of 60 day endpoint impossible and necessitate a new study?  I hope I am wrong.

I really don't think anyone here knows what's possible or not regarding this.  

 

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11 minutes ago, unckeyherb said:

This makes the most sense but I have a dumb question.  The OLE basically moved all the placebo patients on to LL, correct?  When was that done?  Presumably prior to 60 days.  Wouldn't that make an analysis of 60 day endpoint impossible and necessitate a new study?  I hope I am wrong.

I would also think if they are going to look at 42 days or 60 days it will be done with the patients that were in the trial.

However I haven't been able to confirm or not if this is possible.  None of the "experts" on the boards seem to know either

Adding new protocols in after trial is over is generally not allowed but we may be in a special situation here

Edited by Dwayne Hoover
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21 minutes ago, Dwayne Hoover said:

I would also think if they are going to look at 42 days or 60 days it will be done with the patients that were in the trial.

However I haven't been able to confirm or not if this is possible.  None of the "experts" on the boards seem to know either

Adding new protocols in after trial is over is generally not allowed but we may be in a special situation here

Sell to Merck or PFE at $6 and you are approved, don't sell and you need to start a new trial.

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7 hours ago, unckeyherb said:

This makes the most sense but I have a dumb question.  The OLE basically moved all the placebo patients on to LL, correct?  When was that done?  Presumably prior to 60 days.  Wouldn't that make an analysis of 60 day endpoint impossible and necessitate a new study?  I hope I am wrong.

I don't think it did, You would have to know who the placebo participants were and that was only known last week at the earliest (or whenever the exact date of the unblinding happened).

Edited by Dave RL
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The 60 day end point would help to explain what the delay is here.  Last patient completed around Feb 15th, 7 days for database lock and then the 22nd of February, they unblind.  This would be in line with the PR we got on Monday.

There really may be something to this.  Hopefully it's for the best if there is.

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4 hours ago, IC FBGCav said:

This thread needs a good vibe.  In my cabin, drunk.  

Cabin was chosen for starlink, thank you Elon.  Paid my 99.00 hopefully will get the equipment in a few months.

That’s awesome. Keep us posted once you get that installed. Really interested to see how that works.

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5 hours ago, IC FBGCav said:

This thread needs a good vibe.  In my cabin, drunk.  

Cabin was chosen for starlink, thank you Elon.  Paid my 99.00 hopefully will get the equipment in a few months.

What is starlink?

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6 hours ago, IC FBGCav said:

This thread needs a good vibe.  In my cabin, drunk.  

Cabin was chosen for starlink, thank you Elon.  Paid my 99.00 hopefully will get the equipment in a few months and two weeks.

Fixed

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32 minutes ago, BassNBrew said:

Elon's outer space inner webs system for poor people in the back woods.

This.  We get 6 mbps down and .5 up here.  Its not bad really expect for ring needs around 2 up to work right.  Starlink should be 100 mbps plus down and over 20 up.  For 100 bucks a month.  Current paying 65 dollars.

Edited by IC FBGCav
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I try to find the signs that point to good things but overall my sentiment is seriously waning.

You have to suspend so much rational belief in order for this to come out on the other side the way we want it to.

I'm definitely conflicted at times because I want that lottery ticket but it doesn't add up rationally if you just look at this with no emotion tied to it.

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If the results don't blow it out, it's really hard to imagine the FDA is going to approve this tiny biotech with no proven track record.  NP doesn't even inspire confidence in us but the FDA is going to risk it?

That we haven't seen any results yet, is not adding up. Maybe it got unblinded more recently than we thought, I can even suspend disbelief on that one.  But then I need to imagine that the results are great on top of that and NP hasn't said a word.

Where is any mainstream publication showing any signs that they are even following this company?  Certainly someone with some inside knowledge would have talked to someone where this would eventually trickle out.   I don't think its "necessarily" in the FDAs best interest to blindside the country about this company that no one has heard of either.  If they are really going to approve this, I think they would want to start rallying some knowledge and there would be leaks. 

The last part is of course more of my opinion but makes sense to me.

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48 minutes ago, chet said:

Every day that passes with no news makes me more confident that it will be good when it does come.

just a gut feeling or does the lack of info tell you something specific (like they are in negotiations for roll out, etc.)?  

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1 minute ago, unckeyherb said:

just a gut feeling or does the lack of info tell you something specific (like they are in negotiations for roll out, etc.)?  

To me, it means that Nader is addressing logistical issues with the FDA and the British and Canadian equivalents. It's complicated to figure out production, distribution within the US and then negotiating supply for the foreign countries. Apart from manufacturing, these are not issues the company is familiar with and the FDA doesn't want to approve and then have it fail because of logistics.

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13 minutes ago, unckeyherb said:

just a gut feeling or does the lack of info tell you something specific (like they are in negotiations for roll out, etc.)?  

Also because FDA has had raw data for some time and they haven't pulled OLE or eIND usage.  This all points to some kind of approval IMO.

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31 minutes ago, chet said:

To me, it means that Nader is addressing logistical issues with the FDA and the British and Canadian equivalents. It's complicated to figure out production, distribution within the US and then negotiating supply for the foreign countries. Apart from manufacturing, these are not issues the company is familiar with and the FDA doesn't want to approve and then have it fail because of logistics.

Any chance the FDA is recommending a joint venture with a larger Pharma company?  I'm sure they can't officially state that, but more like someone pulling NP aside and gently explaining that he is not capable of the logistics outlined above?  

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5 minutes ago, unckeyherb said:

Any chance the FDA is recommending a joint venture with a larger Pharma company?  I'm sure they can't officially state that, but more like someone pulling NP aside and gently explaining that he is not capable of the logistics outlined above?  

Anything and everything is on the table.  I am sure the FDA is concerned with Nader's "capabilities".

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1 hour ago, chet said:

  I am sure the FDA is concerned with Nader's "capabilities".

Of course they are and if NP has been stubborn about trying to partner up until this point, then that's another thing he's screwed up.

No idea if true because that would mean that another party actually needs to be interested.

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35 minutes ago, Dwayne Hoover said:

Of course they are and if NP has been stubborn about trying to partner up until this point, then that's another thing he's screwed up.

No idea if true because that would mean that another party actually needs to be interested.

Do you think they'll have a problem attracting a partner if the results are good/spectacular?

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17 minutes ago, chet said:

Do you think they'll have a problem attracting a partner if the results are good/spectacular?

I couldn't imagine working with Nader.  The only reason anyone knows about this product is because of Patterson, and NP sold him down the river.  The guy is greasy.

Saying that, I am sure a big company would partner with anyone if the price was right, and you had an imminent approval.

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1 hour ago, chet said:

Do you think they'll have a problem attracting a partner if the results are good/spectacular?

No, they certainly would attract one then.

I'm imagining that there has been interest prior to that point though.  Just don't know how stubborn NP has been in trying to secure things so that this can move along quickly.

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I’m generally back to be 65% confident I just don’t want to see any more PRs or those stupid paid videos until results. Those things are all nightmares and it’s astonishing he hasn’t learned that. 

Edited by Capella
I also have quite a bit less than I did before
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1 hour ago, IC FBGCav said:

What's holding up the uplist?  

With so much volatility either way, I am sure NASDAQ wants to see results before uplisting.  Could you imagine if they uplisted and then announced bad results?  There'd be a lot of egg on NASDAQ's face.

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Someone on Reddit posted that the unblinding date appears to be Feb 12.  If that's true, the FDA has had the raw data for a long time which augers well for CYDY IMO.

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