It's not too early to make a judgment, Craig, you
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Posted On: 10/30/2021 10:55:32 PM
Re: craigakess #109272
It's not too early to make a judgment, Craig, you are going on less information than some of us have.
I got this in a PDF format so I am only going to re-type some excerpts from the Refuse To File letter. I think this is enough to see who is at fault.
Whatever the ADBL datasets are, they are crucial information that Amarex did not supply:
again, stuff that the medical pros here probably understand, but even if we don't know specifics, it's obvious that this is a serious breach:
So they HAD the data but incompetently DID NOT INCLUDE them in the right place.
And then, how often do you think the FDA puts this kind of criticism in an RTF letter?
There's more, but this should give everyone enough to see that this is not the level of professional services that 66 million dollars should buy for a company.
I got this in a PDF format so I am only going to re-type some excerpts from the Refuse To File letter. I think this is enough to see who is at fault.
Whatever the ADBL datasets are, they are crucial information that Amarex did not supply:
Quote:
"However, the ADBL datasets do not include grading. Graded laboratory abnormalities are STANDARD and important."
again, stuff that the medical pros here probably understand, but even if we don't know specifics, it's obvious that this is a serious breach:
Quote:
"....entries are present in CM.xpt but missing in ADCM..."
So they HAD the data but incompetently DID NOT INCLUDE them in the right place.
And then, how often do you think the FDA puts this kind of criticism in an RTF letter?
Quote:
"Of note, the data quality issues described below, which are extensive, 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."
There's more, but this should give everyone enough to see that this is not the level of professional services that 66 million dollars should buy for a company.
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