Today was not a day for speculative plays. Trouble ahead Casey JonesUp 9%, closed down 9%. Today. Fun stock.
I expected the dip into the 3's a couple days ago. It's been very unpredictable this week.fully expecting a dip into the $3's tomorrow.
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.
And today seems to be the opposite, so far.SFBayDuck said:Up 9%, closed down 9%. Today. Fun stock.
Is it not calculated from the trial end date of 12/16?60 days is in two more weeks.
When the next two weeks are up.
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.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.
I was making a joke. It's always two weeks away with this stock.Is it not calculated from the trial end date of 12/16?
I really don't think anyone here knows what's possible or not regarding this.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.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.
Sell to Merck or PFE at $6 and you are approved, don't sell and you need to start a new trial.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
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).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.
That’s awesome. Keep us posted once you get that installed. Really interested to see how that works.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?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.
FixedThis 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.
Elon's outer space inner webs system for poor people in the back woods.What is starlink?
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.Elon's outer space inner webs system for poor people in the back woods.
just a gut feeling or does the lack of info tell you something specific (like they are in negotiations for roll out, etc.)?Every day that passes with no news makes me more confident that it will be good when it does come.
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.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.just a gut feeling or does the lack of info tell you something specific (like they are in negotiations for roll out, etc.)?
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?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.
Anything and everything is on the table. I am sure the FDA is concerned with Nader's "capabilities".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?
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.I am sure the FDA is concerned with Nader's "capabilities".
Do you think they'll have a problem attracting a partner if the results are good/spectacular?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.
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.Do you think they'll have a problem attracting a partner if the results are good/spectacular?
No, they certainly would attract one then.Do you think they'll have a problem attracting a partner if the results are good/spectacular?
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.What's holding up the uplist?