Another fine post! Enjoy: Aaron "The first
Post# of 154644
(Total Views: 597)
Posted On: 11/05/2021 7:45:04 AM
Another fine post! Enjoy:
Aaron
"The first question I have for Amarex is based on the deficiencies in the HIV BLA, how much time did they feel they needed to competently complete it?
The RTF highlighted huge swaths if incompetence.
Over 1000 blank entries ( AND that's for data they actually had. The reviewer saw the data in one set of files and questioned why it wasn't included in the other.)
In perverse irony, the reviewer rebuked Amarex for FILLING IN fields that were supposed to be left blank, ordering the data removed.
So what time frame were they giving NP for the BLa submission?
In the controversial email, NP says he was told by Kush Dhody that the CMC portion would need a week (it was still deficient when submitted).
Was the clinical portion going to take an extra month? A year? Two years?
If they were giving NP estimates of a week or two to completion then it would be a natural expectation that a few fields might be missing but not enough to seriously jeopardize the BLA.
With NP mentioning a week in the email for CMC (which although deficient wasn't too far off the mark, needing minor additional work apparently) could Amarex be warning NP that the clinical section would take months or years?
Page 8 says Amarex outlined a work protocol, it was approved by the FDA and then proceeded to do an unapproved work protocol instead. I'm certain that wasn't discussed with NP"
Aaron
"The first question I have for Amarex is based on the deficiencies in the HIV BLA, how much time did they feel they needed to competently complete it?
The RTF highlighted huge swaths if incompetence.
Over 1000 blank entries ( AND that's for data they actually had. The reviewer saw the data in one set of files and questioned why it wasn't included in the other.)
In perverse irony, the reviewer rebuked Amarex for FILLING IN fields that were supposed to be left blank, ordering the data removed.
So what time frame were they giving NP for the BLa submission?
In the controversial email, NP says he was told by Kush Dhody that the CMC portion would need a week (it was still deficient when submitted).
Was the clinical portion going to take an extra month? A year? Two years?
If they were giving NP estimates of a week or two to completion then it would be a natural expectation that a few fields might be missing but not enough to seriously jeopardize the BLA.
With NP mentioning a week in the email for CMC (which although deficient wasn't too far off the mark, needing minor additional work apparently) could Amarex be warning NP that the clinical section would take months or years?
Page 8 says Amarex outlined a work protocol, it was approved by the FDA and then proceeded to do an unapproved work protocol instead. I'm certain that wasn't discussed with NP"
(7)
(0)