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Posted On: 02/16/2022 10:38:44 AM
Post# of 148887
Re: Crujones1985 #118255
Amarex data concerns come up a lot. From what I understand, Dr Recknor went straight to the trial sites to get the information we were missing. What we don’t have (yet) is an audit of how Amarex collected, stored, and utilized said data when they received it. Early evidence is that they did a piss poor job, whether purposely or through ignorance.
In other words, we shouldn’t be delayed on the BLA any longer than we already have been, but what we may find through an audit is poorly collected and improperly compiled data across all trials they’ve led for us. If the database is constructed poorly, you can’t really trust the analysis of it.
Garbage in, garbage out.
Judging by Amarex’s inability to provide data to the FDA for the BLA (they were told numerous times and even chastised for failing to adjust their methods and submit proper information) it’s entirely reasonable to think they based their analysis on a faulty database of their own creation. One example is the patient who was listed as deceased and then listed with a reported side effect a month later as if alive.
The data is the data, but if Amarex didn’t take care of it properly, their ensuing analysis would be flawed. There was something said to that extent from the FDA, I believe, where they stated that the trial data may be flawed. They were apparently calling into question Amarex’s methods, not necessarily the trial design.
I hope, and anticipate, that once the audit occurs there will be some substantial bookkeeping errors found that, upon correction and reanalysis, actually improve our results rather than detract from them.
I don’t believe it will be so large that we are immediately granted an approval, but impactful enough that our understanding and expectations around Leronlimab’s efficacy will be fortified substantially.
They may even find some collusion or purposeful fuckery (statistical term) involved. I’d love to find out that Sidley gets to go after both Amarex and their parent company with both barrels, safeties off.
It’ll take a long time to result in damages, if that’s what happens, but I’m here for it.
In other words, we shouldn’t be delayed on the BLA any longer than we already have been, but what we may find through an audit is poorly collected and improperly compiled data across all trials they’ve led for us. If the database is constructed poorly, you can’t really trust the analysis of it.
Garbage in, garbage out.
Judging by Amarex’s inability to provide data to the FDA for the BLA (they were told numerous times and even chastised for failing to adjust their methods and submit proper information) it’s entirely reasonable to think they based their analysis on a faulty database of their own creation. One example is the patient who was listed as deceased and then listed with a reported side effect a month later as if alive.
The data is the data, but if Amarex didn’t take care of it properly, their ensuing analysis would be flawed. There was something said to that extent from the FDA, I believe, where they stated that the trial data may be flawed. They were apparently calling into question Amarex’s methods, not necessarily the trial design.
I hope, and anticipate, that once the audit occurs there will be some substantial bookkeeping errors found that, upon correction and reanalysis, actually improve our results rather than detract from them.
I don’t believe it will be so large that we are immediately granted an approval, but impactful enough that our understanding and expectations around Leronlimab’s efficacy will be fortified substantially.
They may even find some collusion or purposeful fuckery (statistical term) involved. I’d love to find out that Sidley gets to go after both Amarex and their parent company with both barrels, safeties off.
It’ll take a long time to result in damages, if that’s what happens, but I’m here for it.
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