Does everyone remember waiting on pins and needles for our different trial results to be released after each one concluded, only to wake up day after day without a PR?
It took forever each time.
Which we all chalked up to industry standards, lots of data to sift through, and a variety of other staple excuses of the eager investor. But ultimately none of us really knew what was going on and this filing sheds some light on what must have been quite the struggle to get Amarex to just do their damn job correctly.
Consider this excerpt from PaitentLong's breakdown of the filing's details:
"1. Amarex was evidently failing its responsibilities to properly categorize, organize, and analyze the data for HIV trials (67 patients) and NASH (25 patients I believe?).
2. CYDY discovered this when it reviewed a snapshot of the information, which lacked any proper headings among other glaring holes in the data."
This isn't a case of a company being held to an unreasonable standard, or some sort of grey area both sides disagree on. It's a company not even performing the basics of Clinical Data Management, which is an extremely important part of any CRO's job. Arguably the most important.
From a 2012 article about clinical data management:
Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing. Team members of CDM are actively involved in all stages of clinical trial right from inception to completion. They should have adequate process knowledge that helps maintain the quality standards of CDM processes. Various procedures in CDM including Case Report Form (CRF) designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking are assessed for quality at regular intervals during a trial.
Imagine wanting to analyze the data from your trial but your CRO decided they couldn't be bothered to properly build a master database? They apparently didn't build the damn thing correctly, let alone enter all the information properly once they had it. "All done," says Kush Dhody as he dumps a pile of marked up bar napkins out on the table. "I glanced at a couple and either you hit your end point or got some digits from a girl at the bar. That'll be 80 million. Let me know if I can be of any more help."
And this isn't just CD10 and CD12. We're apparently talking HIV and NASH patients. They've unnecessarily bogged down just about everything Cytodyn has been trying to accomplish for years. I don't think it was due to anything other than incompetence, by the way. Just a bit of massively bad luck to add to the rest of our gut punches.
It really sheds additional light on the struggle NP has been engaged in trying to get these trials and BLA submissions over the finish line. It's like he's been saddled with an anvil on each leg while trying to carry CYDY through one of those mud runs that were all the rage for a couple years.
As we learn more about some of these relationships I can't help but be thankful that, despite catching bad break after bad break, LL keeps showing it's promise. It'll get there despite the 13d(bags), despite the asshole(s) at the FDA who decided to put out a somewhat unprecedented hit piece during trading hours, and despite Amarex. Who turned out to be massively inept at their job.
And it'll get there because of NP and the current team, who continues to trudge through the bullshit with optimism and tenacity. I know how I'm voting and it ain't for the dbags.
It took forever each time.
Which we all chalked up to industry standards, lots of data to sift through, and a variety of other staple excuses of the eager investor. But ultimately none of us really knew what was going on and this filing sheds some light on what must have been quite the struggle to get Amarex to just do their damn job correctly.
Consider this excerpt from PaitentLong's breakdown of the filing's details:
"1. Amarex was evidently failing its responsibilities to properly categorize, organize, and analyze the data for HIV trials (67 patients) and NASH (25 patients I believe?).
2. CYDY discovered this when it reviewed a snapshot of the information, which lacked any proper headings among other glaring holes in the data."
This isn't a case of a company being held to an unreasonable standard, or some sort of grey area both sides disagree on. It's a company not even performing the basics of Clinical Data Management, which is an extremely important part of any CRO's job. Arguably the most important.
From a 2012 article about clinical data management:
Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing. Team members of CDM are actively involved in all stages of clinical trial right from inception to completion. They should have adequate process knowledge that helps maintain the quality standards of CDM processes. Various procedures in CDM including Case Report Form (CRF) designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking are assessed for quality at regular intervals during a trial.
Imagine wanting to analyze the data from your trial but your CRO decided they couldn't be bothered to properly build a master database? They apparently didn't build the damn thing correctly, let alone enter all the information properly once they had it. "All done," says Kush Dhody as he dumps a pile of marked up bar napkins out on the table. "I glanced at a couple and either you hit your end point or got some digits from a girl at the bar. That'll be 80 million. Let me know if I can be of any more help."
And this isn't just CD10 and CD12. We're apparently talking HIV and NASH patients. They've unnecessarily bogged down just about everything Cytodyn has been trying to accomplish for years. I don't think it was due to anything other than incompetence, by the way. Just a bit of massively bad luck to add to the rest of our gut punches.
It really sheds additional light on the struggle NP has been engaged in trying to get these trials and BLA submissions over the finish line. It's like he's been saddled with an anvil on each leg while trying to carry CYDY through one of those mud runs that were all the rage for a couple years.
As we learn more about some of these relationships I can't help but be thankful that, despite catching bad break after bad break, LL keeps showing it's promise. It'll get there despite the 13d(bags), despite the asshole(s) at the FDA who decided to put out a somewhat unprecedented hit piece during trading hours, and despite Amarex. Who turned out to be massively inept at their job.
And it'll get there because of NP and the current team, who continues to trudge through the bullshit with optimism and tenacity. I know how I'm voting and it ain't for the dbags.
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