Quote:I hope they didn't slow enrollments to save money. I am reminded of an english saying "penny wise, pound foolish". Please say that go slow is not true ?
I'm going to disagree with the other responses to your post. And the reason I going to disagree is because I track this data point very carefully.
Here are the facts:
August 25, 2020 -- 195 Enrolled
CytoDyn Reaches Enrollment of 195 Patients in its Phase 3 Trial for COVID-19 Patients with Severe-to-Critical Symptoms
Source Link: https://www.cytodyn.com/investors/news-events...ts-phase-3
September 29, 2020 -- ~220 Enrolled
CytoDyn to Hold 2020 Virtual Annual Meeting of Stockholders
Source Link: https://edge.media-server.com/mmc/p/oofoxd3c
October 7, 2020 -- ~221 (see 3:53 in video link below)
Dr. Harish Seethamraju: “A Phase 2 Study of Leronlimab for Mild to Moderate Coronavirus Disease 2019 (COVID-19)”
Source Link: https://d1io3yog0oux5.cloudfront.net/cytodyn/...tation.mp4
Note: Slide indicates 220 -- but Dr.HS verbally says around 221
Historical Calculations -- Enrollment Between Interim on August 25 and Dr.HS's presentation on October 7
The number of days between August 25 and October 7 = 43 days
The number of patients enrolled between August 25 and October 7 (221-195) = 26 patients
The average number of patients enrolled per day = 0.60 patients
CytoDyn has repeatedly claimed that they have the ability to more than triple the per-day enrollment in order to get to 390 patients by December 31. To be more specific, the multiple is actually 3.2884.
Supporting Calculations -- CytoDyn Claims It Can Achieve Full Enrollment from October 7 to December 31
The number of days between October 7 and December 31 = 85 days
The difference of patients between 221 and 390 = 169 patients
The average number of patients necessary to enroll per day = 1.98 patients
Multiple: 1.98 patients per day divided by 0.60 patients per day = 3.2884 multiple
How exactly can CytoDyn now assure shareholders that they can increase the historical enrollment rate by 3.3 times in order to get to full enrollment by December 31? The only reliable way to achieve that is by throwing a switch that has been completely under their control since August 25. This is obviously a gating function, and CytoDyn has the ability to open the gate.
So yes, in my opinion, every indication supports the thesis that they slow-rolled the trial enrollment. Since all of the participating trial sites were listed as "Recruiting" on the ClinicalTrials.gov website, this shortsighted strategy and abysmal enrollment rate is unlikely to have been caused by the actions of the Principal Investigators or the availability of willing participants.
Source Link: https://clinicaltrials.gov/ct2/show/NCT04347239
Using very basic reasoning and logic, if back on August 25 CytoDyn had simply applied the enrollment leverage they claim to currently have, then we would be at 327.36 patients as of today.
Supporting Calculations
The number of days between August 25 and October 18 = 54 days
The number of patients that could have been enrolled at 1.98 per day = 107.36 patients
The sum of patients: 220 + 107.36 = 327.36 patients
The worst part of this story is that if CytoDyn had simply done this, we'd only need 62.63 patients to achieve full enrollment. And at an enrollment rate of 1.98 patients per day, we would have achieved full enrollment in 31.50 days on November 18. And extending that to its logical conclusion, the fully-enrolled trial would be have been completely over 28 days later on December 16.
Conclusion
It is obviously a mistake to use static average enrollment rates in these types of calculations. The real world does not operate in this fashion. However, these calculations provide a framework that can be used to arrive at some general conclusions.
I believe CytoDyn made a calculated decision preserve capital and slow down the CD12 trial enrollment. While I respect and admire their efforts to manage trial expenses, this strategy makes absolutely no sense in the context of Dr.NP repeatedly claiming that it would be very unlikely for the trial to be halted at the interim analysis. If a trial halt was so improbable at interim analysis -- then why on earth did they slow down enrollment? In my opinion, this represents a bad strategic decision, and one that can be added to other bad decisions rendered this year.
I'm not here to win a popularity contest or to display blind and misguided optimism. I have neither the time nor the appetite for mindless pumping and I don't care how many "Likes" or "Dislikes" I get.
I care only about actionable facts -- trying to learn them by myself -- and trying to learn them from other intelligent people on this board (you know who you are). Everyone knows that I'm not perfect and that I make mistakes. However, if the quest for facts doesn't square into your investment thesis, then you should probably put me on "Ignore", if you haven't done so already.
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