More from Aaron, at YMB, about the RTF:
"It's about to get serious folks.
Here is looking a page eight from the RTF where the FDA reviewer describes all the data that Amarex failed to include.
Center page:
What is listed are the missing start and end dates of Adverse Events(AE) from the BLA.
Cursory glance shows one type of AE has ten incomplete start dates and five missing or incomplete end dates.
Another type of AE has 2 incomplete start dates and five missing or incomplete.
The third type of AE in that section has a whopping 45 missing start dates and 49 incomplete or missing end dates!
this isn't about science! This is a data collection service! They can't even collect start and end date information? Can you imagine any serious timeline critical data management service in any field that did that? (imagine if Pacer was missing start and end dates for trials and motion documents) Any Data Collection where not including dates would be considered acceptable?
Lower third of RTF page 8:
"However, the ADBL datasets do not include grading. Graded laboratory abnormalities are STANDARD and IMPORTANT."
We don't need to know the science behind ADBL datasets. What is important is that information about them is Missing and I highlighted the FDA reviewers stern rebuke when he says these are STANDARD and IMPORTANT!
Are we to believe the CEO of Amarex doesn't know "standard" and "important" data that must be collected?
But so far we are talking about egregiously not having information to collect! Can it get worse? YES!
How about the bottom most paragraph.
"... entries are present in CM.xpt but missing in ADCM..."
This is off the mark egregious! For this particular scientific information, the FDA reviewer is pointing out Amarex HAS THE DATA! It's "present" in the .xpt files but the FDA reviewer is saying that same data which apparently must be also included in the ADCM is Missing! It hasn't been added!!!
You want to argue Amarex can't include data they don't have? How about explaining why they can't even include data they do have? There is absolutely no excuse for not being able to even copy necessary data over to where proper!!!
All of this brings us back to the top of page 8 which the FDA reviewer uses to preface these deficiencies.
"Of note, the data quality issues described below, which are extensive,.... (and which we just went through ourselves)...may indicate that the process used to collect data from the CRF's WAS FLAWED! If that is the case, additional errors may become apparent during BLA review."
You don't need to understand science to understand what the implications the FDA reviewer is saying.
This is what Amarex submitted based on THEIR data collection and an FDA reviewer has reason to believe THEIR "process used to collect data is flawed".
I guarantee you this is going to also be part of the arbitration!
Part three coming soon... And yes, it gets even worse!"
"It's about to get serious folks.
Here is looking a page eight from the RTF where the FDA reviewer describes all the data that Amarex failed to include.
Center page:
What is listed are the missing start and end dates of Adverse Events(AE) from the BLA.
Cursory glance shows one type of AE has ten incomplete start dates and five missing or incomplete end dates.
Another type of AE has 2 incomplete start dates and five missing or incomplete.
The third type of AE in that section has a whopping 45 missing start dates and 49 incomplete or missing end dates!
this isn't about science! This is a data collection service! They can't even collect start and end date information? Can you imagine any serious timeline critical data management service in any field that did that? (imagine if Pacer was missing start and end dates for trials and motion documents) Any Data Collection where not including dates would be considered acceptable?
Lower third of RTF page 8:
"However, the ADBL datasets do not include grading. Graded laboratory abnormalities are STANDARD and IMPORTANT."
We don't need to know the science behind ADBL datasets. What is important is that information about them is Missing and I highlighted the FDA reviewers stern rebuke when he says these are STANDARD and IMPORTANT!
Are we to believe the CEO of Amarex doesn't know "standard" and "important" data that must be collected?
But so far we are talking about egregiously not having information to collect! Can it get worse? YES!
How about the bottom most paragraph.
"... entries are present in CM.xpt but missing in ADCM..."
This is off the mark egregious! For this particular scientific information, the FDA reviewer is pointing out Amarex HAS THE DATA! It's "present" in the .xpt files but the FDA reviewer is saying that same data which apparently must be also included in the ADCM is Missing! It hasn't been added!!!
You want to argue Amarex can't include data they don't have? How about explaining why they can't even include data they do have? There is absolutely no excuse for not being able to even copy necessary data over to where proper!!!
All of this brings us back to the top of page 8 which the FDA reviewer uses to preface these deficiencies.
"Of note, the data quality issues described below, which are extensive,.... (and which we just went through ourselves)...may indicate that the process used to collect data from the CRF's WAS FLAWED! If that is the case, additional errors may become apparent during BLA review."
You don't need to understand science to understand what the implications the FDA reviewer is saying.
This is what Amarex submitted based on THEIR data collection and an FDA reviewer has reason to believe THEIR "process used to collect data is flawed".
I guarantee you this is going to also be part of the arbitration!
Part three coming soon... And yes, it gets even worse!"
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