#17626
Re: Novavax (NVAX): Un Nuevo Comienzo
Parece que algo mentía el amigo Stan. Y sí, los problemas son los de la validación de los métodos de ensayo de la producción. Lo que garantiza que lo producido pasa los controles de calidad y tiene las cantidades esperadas.
Red- Can you explain further why they are handling the US Phase III data they way they are?
No I can’t
I know what the protocol says but them saying they are extending ph3 to follow for events makes no sense. Stan said that. In stark contrast Flip did not, he said trial is over no more events. Why not filing yet? Entirely due to failures in CMC and test methods validation. In one of the most clueless comments I have ever heard from a CEO Stan commented that ‘did you know that these biologic tests have to be qualified and validated is sequence’ . This sounded so naive and so clueless it amazed me. Duh. Seems like he just learned this. But this is a true operational failure. It has nothing to do with raw materials. It’s something they should have started on in phase 1. The failure of assay qualification and validation is said to be THE reason they are not filing in US. This is 100% on Stan and getting a team to do this. Validation is not easy but it is straight forward, it’s just a lot of work. If resources were not put on validation six or ten months ago it’s a straight forward disaster of their own making. This is job one. And it is not in any way shape or manner related to raw materials or any facility/contract production space. The board should fire Stan. This much is clear.
The failure of SNY was a very simple assay for protein content. High school labs teach these assays. In moving from one lab to another the ball got dropped. I did some math on what they reported and it looks like somebody forgot to use the extinction coefficient in calculating protein. This is so basic it boggles the mind.
The assay that has boggled NVAX appears to be the key bio assay used for potency. This is often a mouse injection type assay, wait 10-14 days bleed the mice and test the antibodies. That is pretty standard in vaccines. Not positive but it sounds like it’s the potency assay . Not impossible but a lot harder than a protein assay that SNY screwed the pooch on.
The ability to compare lot to lot and facility to facility is the potency assay. Not validating this was/is a major failure , it should have been started at phase 1.
Validation is needed for an approval not for Phase 2 or even for phase 3. What I said was they should have been working on assay validation from phase 1 on. Robustness and qualification work etc all precede a full validation. By the time you get to phase 3 you should have it locked in and KNOW it is reliable (robustness) but formal validation is usually done at time Ph3 is started. Any pre phase 3 meeting with FDA should show validation plans.
The assay will be the same at all sites. There are likely a dozen or so other assays measuring various qualities lije particle size/distribution. Total protein sterility...
I know what the protocol says but them saying they are extending ph3 to follow for events makes no sense. Stan said that. In stark contrast Flip did not, he said trial is over no more events. Why not filing yet? Entirely due to failures in CMC and test methods validation. In one of the most clueless comments I have ever heard from a CEO Stan commented that ‘did you know that these biologic tests have to be qualified and validated is sequence’ . This sounded so naive and so clueless it amazed me. Duh. Seems like he just learned this. But this is a true operational failure. It has nothing to do with raw materials. It’s something they should have started on in phase 1. The failure of assay qualification and validation is said to be THE reason they are not filing in US. This is 100% on Stan and getting a team to do this. Validation is not easy but it is straight forward, it’s just a lot of work. If resources were not put on validation six or ten months ago it’s a straight forward disaster of their own making. This is job one. And it is not in any way shape or manner related to raw materials or any facility/contract production space. The board should fire Stan. This much is clear.
The failure of SNY was a very simple assay for protein content. High school labs teach these assays. In moving from one lab to another the ball got dropped. I did some math on what they reported and it looks like somebody forgot to use the extinction coefficient in calculating protein. This is so basic it boggles the mind.
The assay that has boggled NVAX appears to be the key bio assay used for potency. This is often a mouse injection type assay, wait 10-14 days bleed the mice and test the antibodies. That is pretty standard in vaccines. Not positive but it sounds like it’s the potency assay . Not impossible but a lot harder than a protein assay that SNY screwed the pooch on.
The ability to compare lot to lot and facility to facility is the potency assay. Not validating this was/is a major failure , it should have been started at phase 1.
Validation is needed for an approval not for Phase 2 or even for phase 3. What I said was they should have been working on assay validation from phase 1 on. Robustness and qualification work etc all precede a full validation. By the time you get to phase 3 you should have it locked in and KNOW it is reliable (robustness) but formal validation is usually done at time Ph3 is started. Any pre phase 3 meeting with FDA should show validation plans.
The assay will be the same at all sites. There are likely a dozen or so other assays measuring various qualities lije particle size/distribution. Total protein sterility...
