![](http://investorshub.advfn.com/images/default_ih_profile2_4848.jpg?cb=0)
Wednesday, February 16, 2022 11:42:49 AM
suacier
"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. 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!"
Recent CYDY News
- Form SC TO-I/A - Tender offer statement by Issuer: [Amend] • Edgar (US Regulatory) • 07/22/2024 01:00:58 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 07/09/2024 09:17:48 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 07/09/2024 09:16:28 PM
- Form SC TO-I/A - Tender offer statement by Issuer: [Amend] • Edgar (US Regulatory) • 07/09/2024 09:16:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/09/2024 12:46:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/03/2024 09:15:10 PM
- Form SC TO-I - Tender offer statement by Issuer • Edgar (US Regulatory) • 06/03/2024 09:10:56 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/06/2024 09:17:30 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/06/2024 09:16:24 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/06/2024 09:09:58 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/09/2024 02:30:20 AM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 03/01/2024 10:16:47 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 03/01/2024 10:15:34 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 02/22/2024 10:16:11 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 02/22/2024 05:15:08 AM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 02/16/2024 02:00:24 AM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/12/2024 10:31:57 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 01/29/2024 10:22:17 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/29/2024 01:40:14 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 01/19/2024 10:15:35 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 01/16/2024 10:16:04 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2024 02:04:57 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2024 02:04:20 AM
Maybacks Global Entertainment and ZEASN Technology Private Ltd. Sign Global Licensing Agreement • AHRO • Aug 8, 2024 7:00 AM
SANUWAVE Will Host a Conference Call on August 13, 2024 at 8:30 AM (ET) to Present Q2 Financial Results • SNWV • Aug 8, 2024 6:59 AM
Kona Gold Beverage Inc. Signs Letter of Intent with Bemax, Inc. to Sell Kona Gold, LLC • BMXC • Aug 7, 2024 10:00 AM
Btab Ecommerce Group, Inc. Launches Investor Connect AI Chatbot for Enhanced Investor Engagement and Lead Generation • BBTT • Aug 7, 2024 9:00 AM
Hydromer, Inc. Announces Preliminary Unaudited Second Quarter 2024 Financial Results and Provides Business Update • HYDI • Aug 7, 2024 8:52 AM
North Bay Resources Announces Mt. Vernon Gold Mine Startup, Sierra County, California • NBRI • Aug 5, 2024 9:00 AM