(Total Views: 398)
Posted On: 10/14/2021 12:02:21 PM
Post# of 148908
Fortuno,
The lawsuit (attorneys please correct my errors) seeks injunctive relief compelling data handover. I have not read the entirety of the suit, but I believe Cytodyn alleges that data across multiple trials is incomplete and has additionally been withheld after issues discovered by Dr Recknor. I don’t know whether these actions predate withholding of payment by Cytodyn, but it seems reasonable that payment after 8 years of cooperation would only be in response to Dr Recknor’s discovery of deficiencies.
In part, Dr Recknor stated:
20. Amarex has failed to provide CytoDyn with requested information for work it claims it has performed.
21. One of the ways CytoDyn has confirmed that Amarex is not performing under the MSA and the Work Orders is by downloading a snapshot of the clinical data for certain clinical trials managed by Amarex.
22. This snapshot is incomplete: it does not include the definitions of the EDC fields (i.e., the database’s “column headings”), the audit trails showing each time the data has been modified, the auto-generated “data queries” that are essential to cleaning and maintaining clinical data, or many other of the essential components of the clinical data that can only be obtained through full access to the EDC.
23. The snapshot was not provided by Amarex, but obtained through CytoDyn’s limited access to the EDCs for certain clinical trials. Even this limited access has now been cut off by Amarex, making it impossible for CytoDyn to obtain additional snapshots.
24. It is impossible for CytoDyn to monitor the ongoing trials or to submit applications to the FDA based on the data contained in the snapshots.
25. However, these limited snapshots are enough for CytoDyn to confirm that the clinical data for multiple studies is in disarray, and has not been maintained by Amarex as the parties’ agreements require.“
The proposed decision (which I erroneously posted as a decision rendered by the court), would force Amarex to hand over data.
As discussed previously, Cytodyn will remain responsible to pay the amount decided through arbitration.
The lawsuit (attorneys please correct my errors) seeks injunctive relief compelling data handover. I have not read the entirety of the suit, but I believe Cytodyn alleges that data across multiple trials is incomplete and has additionally been withheld after issues discovered by Dr Recknor. I don’t know whether these actions predate withholding of payment by Cytodyn, but it seems reasonable that payment after 8 years of cooperation would only be in response to Dr Recknor’s discovery of deficiencies.
In part, Dr Recknor stated:
20. Amarex has failed to provide CytoDyn with requested information for work it claims it has performed.
21. One of the ways CytoDyn has confirmed that Amarex is not performing under the MSA and the Work Orders is by downloading a snapshot of the clinical data for certain clinical trials managed by Amarex.
22. This snapshot is incomplete: it does not include the definitions of the EDC fields (i.e., the database’s “column headings”), the audit trails showing each time the data has been modified, the auto-generated “data queries” that are essential to cleaning and maintaining clinical data, or many other of the essential components of the clinical data that can only be obtained through full access to the EDC.
23. The snapshot was not provided by Amarex, but obtained through CytoDyn’s limited access to the EDCs for certain clinical trials. Even this limited access has now been cut off by Amarex, making it impossible for CytoDyn to obtain additional snapshots.
24. It is impossible for CytoDyn to monitor the ongoing trials or to submit applications to the FDA based on the data contained in the snapshots.
25. However, these limited snapshots are enough for CytoDyn to confirm that the clinical data for multiple studies is in disarray, and has not been maintained by Amarex as the parties’ agreements require.“
The proposed decision (which I erroneously posted as a decision rendered by the court), would force Amarex to hand over data.
As discussed previously, Cytodyn will remain responsible to pay the amount decided through arbitration.
(6)
(0)Scroll down for more posts ▼
