Post by marriott on Jul 24, 2021 22:09:17 GMT
Some thoughts on the importance of NVX-CoV2373 and the coming Conference call scheduled August 5, 2021 .
Let's begin by revisiting CEO Erck's earlier statements concerning Regulatory filings associated with 2373 . My comments are highlighted.
He acknowledge that the filings were delayed. During the question session, Mr Erck answered " in part, it has to do with manufacturing at different sites and showing comparability between the processes and the actual end product between the different sites . And you have to develop assays that can follow those and so I think it took longer than we expected to get a potency assay that worked across all the sites. I am happy to say we did. We crossed that bridge. We made a big breakthrough . We are now racing towards validating everything and putting it into a package . "
.... The company has learned and moved forward . Give us more color on the measures put in place to insure consistency and compliance.
At various points , Mr Erck stated the following :
" All facilities in our network have already demonstrated the ability to manufacture commercial scale CMC materials " .
.... How did they demonstrate manufacturing integrity ?
" The filing timetable depends on completing the final phases of qualification and validation of the assays that are needed to complete the demonstration of process consistency and to subsequently finalize the reports for regulatory filings . "
.... We trust qualified individuals highly skilled in this area are monitoring and moving forward .
" It has been a massive effort and has depended on our global manufacturing partners to help us accumulate a suitable data package. This has been a " top priority of the company " .
.... Therefore I will assume you have not commented publicly on the delays because you and the team have been focused on the solutions.
" we expect to complete regulatory filings " and " hope market authorizations during the third quarter " .
.... Just comment completely and factually on the submission. The authorizations are on a timeline beyond the company's control .
At one point Mr Erck stated clearly " now we're giving guidance that nearly all the major challenges have been overcome and we can see the light at the end of the tunnel " .
.... I believe the risk associated with NVX-CoV2373 reaching the market place is significantly less than entry into the commercial space !
So Mr Erck , you have come under fire for delays , stock options , leadership qualities , expressing confidence..... I believe you have grown in experience and leadership . Keep in mind what Jack Welch said years ago - " before you are a leader, success is all about growing yourself. When you become a leader, success is all about growing others " .
SO LET'S GROW !!!!!!
Let's begin by revisiting CEO Erck's earlier statements concerning Regulatory filings associated with 2373 . My comments are highlighted.
He acknowledge that the filings were delayed. During the question session, Mr Erck answered " in part, it has to do with manufacturing at different sites and showing comparability between the processes and the actual end product between the different sites . And you have to develop assays that can follow those and so I think it took longer than we expected to get a potency assay that worked across all the sites. I am happy to say we did. We crossed that bridge. We made a big breakthrough . We are now racing towards validating everything and putting it into a package . "
.... The company has learned and moved forward . Give us more color on the measures put in place to insure consistency and compliance.
At various points , Mr Erck stated the following :
" All facilities in our network have already demonstrated the ability to manufacture commercial scale CMC materials " .
.... How did they demonstrate manufacturing integrity ?
" The filing timetable depends on completing the final phases of qualification and validation of the assays that are needed to complete the demonstration of process consistency and to subsequently finalize the reports for regulatory filings . "
.... We trust qualified individuals highly skilled in this area are monitoring and moving forward .
" It has been a massive effort and has depended on our global manufacturing partners to help us accumulate a suitable data package. This has been a " top priority of the company " .
.... Therefore I will assume you have not commented publicly on the delays because you and the team have been focused on the solutions.
" we expect to complete regulatory filings " and " hope market authorizations during the third quarter " .
.... Just comment completely and factually on the submission. The authorizations are on a timeline beyond the company's control .
At one point Mr Erck stated clearly " now we're giving guidance that nearly all the major challenges have been overcome and we can see the light at the end of the tunnel " .
.... I believe the risk associated with NVX-CoV2373 reaching the market place is significantly less than entry into the commercial space !
So Mr Erck , you have come under fire for delays , stock options , leadership qualities , expressing confidence..... I believe you have grown in experience and leadership . Keep in mind what Jack Welch said years ago - " before you are a leader, success is all about growing yourself. When you become a leader, success is all about growing others " .
SO LET'S GROW !!!!!!