Here is an explanation in more layman terms: Aa
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Posted On: 11/15/2021 8:46:28 AM
Here is an explanation in more layman terms:
Aaron
EXPLAINING THE CYTODYN/AMAREX QUOTES
I put up a bunch of quotes which got copied on Investors hangout and Facebook, some incomplete. A bunch of posters didn't quite understand fully what the totality of these quotes meant so here is my layman explanation.
Sidley's complaint to the court shows that for each and every work order, literally each and every study, there was clear instructions on what Amarex was in charge of.
They actually supplied one complete work order with about three pages of instructions with checkboxes next to who must perform the services (Amarex or Cytodyn) so there is no question as to who is responsible for each aspect of the trial.
Amarex was always listed as maintaining the EDC (Electronic Data Collection). It literally just collects the data from multiple locations so if questions arise, everyone can go to one location (the EDC) for answers.
In these instructions it is made clear that the EDC has software that flags any suspect data (a query). It doesn't answer the query. It's more of a warning!
An ACTUAL example straight from page 13 of the RTF is that patient #301013 from CD03 was reported deceased on June 30, 2019. And that this same patient complained of a "right arm abscess" about a month later.
The EDC should have sent out an immediate auto-query listing the above as incorrect data (even though not supplying an answer) and Amarex should have investigated to see what the true situation was.
The work orders specified that these situations should be updated on a daily basis. If everyone is looking to the EDC for data, it's imperative correct data be maintained. (This is just common sense IMO).
Sidley's complaint states Amarex failed to do that. They left some queries open for months if not years (the dead man who has a right arm abscess was singled out by the FDA reviewer as an example of possible flaws in data collection methods).
Cytodyn is being forced to go physically to all the trial sites to answer these queries. The data is almost certainly there (medical facilities are usually pretty good at keeping records) but there is the danger that these queries can't be satisfactorily answered after so much time has passed. (The answer to how a dead man complains about his arm is simple. Either he isn't dead or there was a mixup with patients. But remembering which it was three years later is going to be an issue. Which is why daily cleanup of queries is so important).
Now here is the kicker!!!!
In the Amarex answer to the court as to why the injunction to give access to the EDC is so important, Kazem Kazempour of Amarex says the EDC ISN'T so important and that's why the injunction isn't necessary.
He states the EDC isn't important because it's filled with unanswered queries because Amarex wasn't fixing them until the study was closed. Amarex expected the doctor's at the trial sites to fix the queries and Amarex would simply update the entirety of the EDC upon study closure.
In his zeal to convince the judge why the EDC access won't even help the plaintiff, Kazempour literally confesses to the very actions Sidley has given cause to in their complaint.
It boggles my mind that Amarex attorneys even allowed such a statement to the court but it's done now and can't be walked back so easily.
WHERE THIS IS MOST LIKELY GOING
Let me requote from Sidley's complaint:
"Amarex has covered up it's failures by making false statements to Cytodyn..."
And Amarex "...has backdated certain records to make it appear that the required visits were timely performed."
Sidley is clearly setting up that these failures were recognized by Amarex and they intentionally mislead and covered up their "failures" and here is why!
Section 9.3 of the MSA between Cytodyn and Amarex states that under no circumstances shall Cytodyn be able to sue for damages above the cost of what was paid to Amarex for any work failures "... PROVIDED HOWEVER that this limitation does not apply in the event of Amarex's gross negligence or WILFUL MISCONDUCT" (Emphasis mine).
Trust me, Sidley is well aware of what they are doing.
So is NSF, Amarex's parent company. In the answer to the complaint, NSF states they should be dismissed from this case for various reasons.
Amarex is a company worth millions. It is owned by NSF which is worth billions. You go after the big fish.
The first four pages of the amended complaint literally is just how NSF is directly connected to Amarex.
By this point you should be understanding why Sidley is making a big deal of NSF and their link to Amarex and where this is most likely going."
Aaron
EXPLAINING THE CYTODYN/AMAREX QUOTES
I put up a bunch of quotes which got copied on Investors hangout and Facebook, some incomplete. A bunch of posters didn't quite understand fully what the totality of these quotes meant so here is my layman explanation.
Sidley's complaint to the court shows that for each and every work order, literally each and every study, there was clear instructions on what Amarex was in charge of.
They actually supplied one complete work order with about three pages of instructions with checkboxes next to who must perform the services (Amarex or Cytodyn) so there is no question as to who is responsible for each aspect of the trial.
Amarex was always listed as maintaining the EDC (Electronic Data Collection). It literally just collects the data from multiple locations so if questions arise, everyone can go to one location (the EDC) for answers.
In these instructions it is made clear that the EDC has software that flags any suspect data (a query). It doesn't answer the query. It's more of a warning!
An ACTUAL example straight from page 13 of the RTF is that patient #301013 from CD03 was reported deceased on June 30, 2019. And that this same patient complained of a "right arm abscess" about a month later.
The EDC should have sent out an immediate auto-query listing the above as incorrect data (even though not supplying an answer) and Amarex should have investigated to see what the true situation was.
The work orders specified that these situations should be updated on a daily basis. If everyone is looking to the EDC for data, it's imperative correct data be maintained. (This is just common sense IMO).
Sidley's complaint states Amarex failed to do that. They left some queries open for months if not years (the dead man who has a right arm abscess was singled out by the FDA reviewer as an example of possible flaws in data collection methods).
Cytodyn is being forced to go physically to all the trial sites to answer these queries. The data is almost certainly there (medical facilities are usually pretty good at keeping records) but there is the danger that these queries can't be satisfactorily answered after so much time has passed. (The answer to how a dead man complains about his arm is simple. Either he isn't dead or there was a mixup with patients. But remembering which it was three years later is going to be an issue. Which is why daily cleanup of queries is so important).
Now here is the kicker!!!!
In the Amarex answer to the court as to why the injunction to give access to the EDC is so important, Kazem Kazempour of Amarex says the EDC ISN'T so important and that's why the injunction isn't necessary.
He states the EDC isn't important because it's filled with unanswered queries because Amarex wasn't fixing them until the study was closed. Amarex expected the doctor's at the trial sites to fix the queries and Amarex would simply update the entirety of the EDC upon study closure.
In his zeal to convince the judge why the EDC access won't even help the plaintiff, Kazempour literally confesses to the very actions Sidley has given cause to in their complaint.
It boggles my mind that Amarex attorneys even allowed such a statement to the court but it's done now and can't be walked back so easily.
WHERE THIS IS MOST LIKELY GOING
Let me requote from Sidley's complaint:
"Amarex has covered up it's failures by making false statements to Cytodyn..."
And Amarex "...has backdated certain records to make it appear that the required visits were timely performed."
Sidley is clearly setting up that these failures were recognized by Amarex and they intentionally mislead and covered up their "failures" and here is why!
Section 9.3 of the MSA between Cytodyn and Amarex states that under no circumstances shall Cytodyn be able to sue for damages above the cost of what was paid to Amarex for any work failures "... PROVIDED HOWEVER that this limitation does not apply in the event of Amarex's gross negligence or WILFUL MISCONDUCT" (Emphasis mine).
Trust me, Sidley is well aware of what they are doing.
So is NSF, Amarex's parent company. In the answer to the complaint, NSF states they should be dismissed from this case for various reasons.
Amarex is a company worth millions. It is owned by NSF which is worth billions. You go after the big fish.
The first four pages of the amended complaint literally is just how NSF is directly connected to Amarex.
By this point you should be understanding why Sidley is making a big deal of NSF and their link to Amarex and where this is most likely going."
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