I haven't seen this stuff about Amarex's failures
Post# of 153871
(Total Views: 494)
Posted On: 02/16/2022 12:07:42 PM
I haven't seen this stuff about Amarex's failures posted here yet. From YMB -
Saucier
3 hours ago
Just some of the most egregious issues with the Amarex case that we know about;
1. Kazem Kazempour of Amarex had a discussion with the FDA reviewer in 2019. A protocol was determined. Nonetheless, Kazempour (a former FDA reviewer himself) changed the protocol with no explanation.
2. Over the course of 18 months the FDA reviewer asks Kazempour to supply RO Assays. After a year and a half, the reviewer scolds Kazempour for ignoring his repeated requests.
3. Thousands of fields of data are missing. (Locations on a form where data is to be entered. - CX) The FDA reviewer notes the data is in their possession because they are in .xpt files. Kazempour did not complete his work.
4. Inexplicably with thousands of fields of missing data, the FDA reviewer asks why Kazempour filled in fields meant to be left blank…
5. Data from different trials is mixed up. The FDA reviewer suggests Amarex has faulty data collection.
6. Patient discrepancy is noted by the FDA reviewer as he again calls into question Amarex collection methods. In particular one patient is reported deceased. But one month later this same patient is complaining about a right arm abscess.
After receiving the RTF, Cytodyn demands an audit of Amarex. Amarex refuses. It is contractually required in the MSA that Amarex must allow an audit and it’s also an FDA regulation.
Cytodyn demands their database information (EDC) and the master trial files to be handed over. Amarex refuses. Again this is in violation of both the MSA contact and FDA regulations.
And that's where we are.
The FDA reviewer kept notes and, at first blush, appeared to have been guiding Kazempour through his responsibilities, but Kazempour failed to do his job.
The BLA appears to have been scuttled by Kazempour through the process. The backdated documents appear to show that it was intentional.
Who knows what else they may find during the audit. This will not end well for Amarex.
Sidley Austin is just days away from delivering the Kill Shot!
Saucier
3 hours ago
Just some of the most egregious issues with the Amarex case that we know about;
1. Kazem Kazempour of Amarex had a discussion with the FDA reviewer in 2019. A protocol was determined. Nonetheless, Kazempour (a former FDA reviewer himself) changed the protocol with no explanation.
2. Over the course of 18 months the FDA reviewer asks Kazempour to supply RO Assays. After a year and a half, the reviewer scolds Kazempour for ignoring his repeated requests.
3. Thousands of fields of data are missing. (Locations on a form where data is to be entered. - CX) The FDA reviewer notes the data is in their possession because they are in .xpt files. Kazempour did not complete his work.
4. Inexplicably with thousands of fields of missing data, the FDA reviewer asks why Kazempour filled in fields meant to be left blank…
5. Data from different trials is mixed up. The FDA reviewer suggests Amarex has faulty data collection.
6. Patient discrepancy is noted by the FDA reviewer as he again calls into question Amarex collection methods. In particular one patient is reported deceased. But one month later this same patient is complaining about a right arm abscess.
After receiving the RTF, Cytodyn demands an audit of Amarex. Amarex refuses. It is contractually required in the MSA that Amarex must allow an audit and it’s also an FDA regulation.
Cytodyn demands their database information (EDC) and the master trial files to be handed over. Amarex refuses. Again this is in violation of both the MSA contact and FDA regulations.
And that's where we are.
The FDA reviewer kept notes and, at first blush, appeared to have been guiding Kazempour through his responsibilities, but Kazempour failed to do his job.
The BLA appears to have been scuttled by Kazempour through the process. The backdated documents appear to show that it was intentional.
Who knows what else they may find during the audit. This will not end well for Amarex.
Sidley Austin is just days away from delivering the Kill Shot!
(5)
(0)