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***OFFICIAL CYDY/Leronlimab Thread*** (4 Viewers)

BassNBrew said:
No worries, I just exited the party earlier closing out all the big wins for $3150 to $3300 last July and August.  Reloaded in the fall in the $2850 to $3150 range.  While the first was a huge win, the later has been a huge opportunity loss as it's lagging everything including CYDY.
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There’s just no telling. I don’t have a crystal ball. Amazon could announce a split tomorrow and it takes off, so I don’t see the gain in trying to time it. 

 
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Capella said:
Seriously though if it was bad news, why hasn’t the OLE been pulled? If there was ever an indicator it’s that. 
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You got me. Only thing I can think of is that it showed an improvement but wasn’t statistically significant so they want more data. Maybe they are using the EUA to increase the sample size. My biggest concern is that the standard of care has improved to the point that The data is corrupted in the the minds of the FDA folks

 
Dave RL said:
All similar trials' placebo wings show that 28 day mortality was around 30% to 33% that puts LL hitting the primary endpoint. 42 day mortality varies more but could be anywhere from 40% to 80%. Given our situation I see the *worst* case situation would be just missing stat significance @ 28 days and having the ability to prove it using a variety of other secondary endpoints or looking at 42 day mortality. I would be surprised to see anything other than an EUA.
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Especially since we know the overall mortality in the trial was around 22.3%.  88/394  Someone told me that he heard there were a total of 88 deaths.

 
BassNBrew said:
You got me. Only thing I can think of is that it showed an improvement but wasn’t statistically significant so they want more data. Maybe they are using the EUA to increase the sample size. My biggest concern is that the standard of care has improved to the point that The data is corrupted in the the minds of the FDA folks
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They enrolled a lot of people in the November/December timeframe and there were a lot of people dying then.

 
chet said:
Especially since we know the overall mortality in the trial was around 22.3%.  88/394  Someone told me that he heard there were a total of 88 deaths.
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If there were 88 deaths, 36 deaths in placebo gives statistical significance.  36/131 = 27.5%.  

 
From my post on the other board:

To keep my expectations in check I am going by the Amarex PR:

Results expected in Q1 2021

Not very precise but Amarex is the subject matter expert and closest to the actual data and process. My guess is that they had an estimate that included a 20% or 30% buffer which probably came out to some time in late March and then just simplified that to Q1 for the PR.

Let's suppose there estimate was about 3/26 and if they had some contingency built in that would work out to:

- 3/26 - 20% = 3/9
- 3/26 - 30% = 2/28

So that is the date range I'm expecting if everything goes nominally.

That would leave us 2 to 3 weeks to go but 2/28 looks like a nice target for them to push towards.

I really hope I'm wrong on the long side though.
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Amarex PR
https://17c1ff56-307b-40f2-aebf-335e9ef8b689.filesusr.com/ugd/2e2b64_c399bb785a69462f9a32d60bb70d89c1.pdf

18 January 2021

Severe-to-Critical COVID-19 Patient Clinical Trial Reaches Full Enrollment

Germantown, MD, USA (January 18, 2021) – Amarex Clinical Research, LLC, an NSF International company, announced a client’s Phase III clinical trial for patients with severe-to-critical COVID-19 symptoms reached full enrollment (390 patients) in mid December. Data analysis results are expected this quarter. The trial was conducted in the U.S., Canada, and U.K..

...... Yadda Yadda Yadda
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Posted on Reddit:

I speak regularly to people who own enormous amounts of shares. Multiple millions. We all believe in the drug but have serious issues with management--specifically, their incompetence, inexperience, and arrogance.

Based largely on Dr. Patterson's discoveries, we know the drug works but are worried about management's ability to construct a trial to highlight the drug's capabilities. CD10 was a poorly designed trial and Nader's PR from 12/24 was incredibly poorly worded. CD10 showed that patients benefitted in a statistically significant and objective way using the NEWS2 score to measure their improvement. This is a cohort of patients that is very difficult to prove improvement because most get better on their own. Combined with the small size of the trial implies that the result was actually very important to show that the drug is effective for the mild/moderate group. Nader's statement in the PR that the "results of our CD10 trial will not support an eIND request," gives ammo to the shorts to say that the trial was a failure. The correct message would have been that a phase 3 trial is the next step for the m/m group but we are focussing on CD12.

Regarding CD12, Nader's silence is significant. It runs opposite to his usual behavior and indicates that he might finally be listening to others. If the results were bad, the FDA would have certainly pulled the open label extension (OLE) that was recently granted. Nader most recently announced that 87 patients had passed away--taking the total deaths to 90 implies a mortality rate of 22.8% (90/394). Placebo arms in other trials with similarly sick patients have showed a mortality rate of 32%. Solving for drug using the above assumptions yields a mortality rate of 18.2% for the drug arm (48/263). Using the Wolfram Alpha two proportion hypothesis test with the above numbers yields a p-value of 0.0017. In fact, you can go to 37/53 placebo/drug deaths (assuming 90 total deaths) to have a significant p-value (0.041)--this assumes mortality rate of 28.2% in placebo.. All of the above assume 131 patients in placebo and 263 in drug.  Here's a link to the 37/53 calculation.

All of the above leads us to believe CD12 will show a significant result or in the worst case, miss narrowly. The FDA knows that there aren't any drugs to treat the severe/critical group and have said they will be flexible in working with companies who have effective treatments. Other drugs with less impressive results than the worst case scenario proposed above have been approved and there's no reason to think they will ignore a drug that will show a big drop in mortality versus placebo.

Stay long and stay strong, longs. Don't let the BS spouted by the #shortmafia scumbags erode your confidence.
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If there are larger trials with death rates for the placebo arm established, why wouldn’t those be allowed by the FDA?  I get that the methodology would add a variable of the timing being different, but wouldn’t it be better to have a much more reliable placebo death rate based on a sample size that is 6-10x larger?  When these tests involve just a couple hundred patients, the difference in a couple deaths can be within the margin of error and potentially bless or kill the drug. 

 
PennState-JD said:
If there are larger trials with death rates for the placebo arm established, why wouldn’t those be allowed by the FDA?  I get that the methodology would add a variable of the timing being different, but wouldn’t it be better to have a much more reliable placebo death rate based on a sample size that is 6-10x larger?  When these tests involve just a couple hundred patients, the difference in a couple deaths can be within the margin of error and potentially bless or kill the drug. 
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Seems to me that there are too many variables between severity of patients and hospital care, just to start, to blanket apply a rate across the board to this particular trial

My biggest fear though is that this trial didn't have enough patients. NP declined the 75% review where they could have been advised to add more.  To me, this was a big risk.

 
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PennState-JD said:
If there are larger trials with death rates for the placebo arm established, why wouldn’t those be allowed by the FDA?  I get that the methodology would add a variable of the timing being different, but wouldn’t it be better to have a much more reliable placebo death rate based on a sample size that is 6-10x larger?  When these tests involve just a couple hundred patients, the difference in a couple deaths can be within the margin of error and potentially bless or kill the drug. 
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All trials have difference inclusion/exclusion criteria and it really needs to be an apples to apples comparison to be valid.  You're right that a couple of deaths either way can swing things wildly.

 
The longer we wait with no info, the more comfortable I become.  Presumably the FDA has some kind of initial read and they would have shut off the eINDs and the OLE if the trial were bad.  Also, CYDY would have to PR or 8K a bad trial because it's material info.  

I know it's tough but stay firm and wait it out.

 
chet said:
The longer we wait with no info, the more comfortable I become.  Presumably the FDA has some kind of initial read and they would have shut off the eINDs and the OLE if the trial were bad.  Also, CYDY would have to PR or 8K a bad trial because it's material info.  

I know it's tough but stay firm and wait it out.
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Would be good to know if the eINDs and OLE were even being used, we haven't heard a word about this other than they have it.

 
chet said:
The longer we wait with no info, the more comfortable I become.  Presumably the FDA has some kind of initial read and they would have shut off the eINDs and the OLE if the trial were bad.  Also, CYDY would have to PR or 8K a bad trial because it's material info.  

I know it's tough but stay firm and wait it out.
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This is the biggest deal IMO.  The silence tells me that the results were good.  I don't recall how long they have to file the 8k but I'm fairly certain that timeline has passed by at this point.

 
Don't think trial results are require an 8k...

Charlie Harper said:
Requirements for Form 8-K
The SEC requires disclosure for numerous changes relating to a registrant's business and operations. Changes to a material definitive agreement or the bankruptcy of an entity must be reported. Other financial information disclosure requirements include the completion of an acquisition, changes in the firm's financial condition, disposal activities, and substantial impairments. The SEC mandates filing an 8-K for the delisting of a stock, failure to meet listing standards, unregistered sales of securities, and material modifications to shareholder rights.1

An 8-K is required when a business changes accounting firms used for certification. Changes in corporate governance, such as control of the registrant or amendments to articles of incorporation, need to be reported. Changes in the fiscal year and modifications of the registrant's code of ethics must also be disclosed.1

The SEC also requires a report upon the election, appointment, or departure of a director or specific officers. Form 8-K must be used to report changes related to asset-backed securities. The form may also be used to meet Regulation Fair Disclosure requirements.1

Form 8-K reports may be issued based on other events up to the company's discretion that the registrant considers to be of importance to shareholders
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Investopedia 8K

Unless I'm not understanding it properly, seems like it's up to CYDY whether this warrants an 8k, which has to be filed in 4 days.

 
Dave RL said:
From Yahoo via iHangout, Pretty much in line with what I guessed.

https://investorshangout.com/post/view?id=6057455
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Its not in line with NP's dates though.  Why would NP saying data unblinded (now two weeks ago) if the database lock was until 2/23?

There really isn't any reason for NP to overpromise dates at this point and I don't see how he could be so wrong about them either.

 
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Yea, could be spurious info from an unknown source but it seems to fit. I think it was Mahboob that said 1 week in the VC.

 
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