Post by marriott on Sept 10, 2021 17:33:31 GMT
The Covid-19 environment put Governments throughout the world in a position to react quickly and decisively . However, global policies varied. Some jurisdictions imposed lockdown policies and others looser policies. Basically over the past many months much debate has occurred regarding the ‘health versus the economy’ trade-off . Some research found " a negative relationship between Covid-19 infection numbers and political approval across countries and time. " .
Now to Novavax....please take the time to read the following . I know it's long but I think you will find it revealing . My main findings were :
Novavax leadership clearly underestimated the changing Covid-19 environment and the response by the global regulatory authorities.
The establishment of the global production and sourcing proved more challenging than envisioned.
They appear to have miscalculated the focus of some of the regulatory authorities . They have hired the necessary talent to address this issue.
I think Novavax has worked very hard and made great strides to move to the market place under difficult and changing circumstances . Yes, all in the arena have but Novavax started with significantly less capital reserves.
The delay in reaching the market place has been very costly to themselves and people in need throughout the world. Obviously , GAVI, SII , SK bioscience , Takeda and the APAs with the EU , UK, Canada , Australia, New Zealand and Switzerland testify to the confidence and belief that Novavax vaccines will reach the arms of millions of people in need
The bottom line - Novavax vaccines are proven safe and effective. I believe Novavax has learned much over the past few months and thay will take that knowledge to move forward and reach the marketplace . So here we go .
_______________________________________________________________________________________
Let’s go back to some comments CEO Erck made during the “ Earnings “ Call held on August 5 , 2021 .
….. “ we filed regulatory submissions in multiple markets in partnership with Serum Institute. These regulatory submissions for emergency use authorization were filed with a Drugs Controller General of India and regulatory agencies in Indonesia, and the Philippines. We expect to file for emergency use listing to the World Health Organization in August . “
Now turning to the U S , “ we’re continuing to work with the FDA in collaboration with our team …. to finalize our filing package for authorization under emergency use authorization. The current timeline looks to now be in the fourth quarter, hopefully early in the fourth quarter. This timeline is based upon a couple of factors. “ He goes on to say - “First, the completion of validation of analytical methods and additionally, we have many complex critical activities as part of our finalization of our authorization submission that are being carried out with multiple third parties. Importantly, I believe all the key components are in place to achieve our filing within the fourth quarter. “
Now moving forward to other filings, CEO Erck states “ we continue to advance our program with the MHRA, which is the UK regulatory agency. We are targeting to submit to MHRA in the third quarter, but as with all applications, this may change based on discussions planned for later this month to support our planned application in the third quarter. Given that there are many countries who will rely on MHRA authorizations as a basis for their own regulatory approvals, this is another important global filing. “
Duirng Q&A :
Representative from Feffries asks…. “how much risk is there associated with addressing some of those last remaining issues that are the gating steps to those filings? “
CEO Erck responds : “Yes. I think the risk reduction is dramatic. I think that it’s a matter of now mechanics of getting all the data – final data assembled and submitted. And it’s – we’re talking weeks here, we’re not talking months. So I’m not worried about the future submissions. “
Mayank Mamtani with B. Riley FBR asks …. “the UK filing that seems to be taking a little longer than maybe that was anticipated. I’m just curious if the Com-COV2 data that is being worked upon also mix and match vaccine data. I’m just curious if you have an update on that and if that data set is playing any role with what is going on in UK. And if you can comment on the CMC side, the first part of that question would be helpful too. “
CEO Erck responds : …… “ So there are two studies that are being funded by the VTF and are being done by University of Oxford and Southampton. One of them has a heterologous vaccination study that you referenced, Com-COV2. And the other one is a boosting study where people receive two doses of other sponsors vaccines and are being boosted by our vaccine. And that’s the cough flu study. Those data – those studies are sponsored by ourselves or sponsored by the universities and we understand the data will be made available and published in the September time frame. …. We’ve discussed this data with the UK regulators and they suggested it would be helpful, but thought that our phase to boost data in conjunction with our South Africa data would really be a desirable to include it in a label indication.
Charles Duncan with Cantor Fitzgerald asks ….. “what is this specific question that you’re looking to get at MHRA or is it a checkup meeting prior to filing an application for or finishing the application for approval in the UK?
John Trizzino responds “ Yes. This we hope would be the final meeting where we’d have the submission after that. We’re looking at the final questions that they come up with and leading to a filing in
September. “
Eric Joseph with JPMorgan asks ….. “ can you speak to what extent the submission packages or requirements differ from those already submitted with a services to for India, Indonesia, and the Philippines. …… just curious to know whether you’re seeing European regulators move the goalposts at all, given that it’s kind of taking this long to complete those submissions. “
CEO Erck responds ….. On the regulatory issues, so every – so we have made products in different plants and use it in different clinical trials. And what is the only difference between what we’re filing with everybody else and what we’re intending to file with the MHRA and EMA is we’re finishing up some comparability work between loss that needs to be done. And those, I think the actual studies are done. And data as we put together and that’s what’s going to take, we gave you this data put together and submit it to the MHRA and so it’s – I have great deal of confidence that that package will go into them on the timetable we just talked about. “
Eric Joseph follows up with “How are you planning to update investors, I guess, as it relates to those package submissions…”
CEO Erck “Well, I think when – obviously when we get an approval, you’ll get a press release. And I think when we file with major agencies like MHRA and EMA, we’ll announce that in a press release. “
Eric Joseph follows with - “ I’m just trying to understand – a better understand some of the language in your most recent filing here, as it relates to your agreement with the U.S. government saying would like to see FDA alignment on your analytical methods before conducting additional U.S. manufacturing. It gives how to understand that those that suggest some kind of authorization for – before continued U.S. production. “
CEO Erck resonds : “Yes, that’s sort of the source of some of the delay with the FDA is we have this USG, the U.S. government that is our partner in developing this vaccine. And they are the gate to are submitting to the FDA. So there’s has to be some negotiation with U.S. government and does the validation activities, meet their standards. And then we take it to the FDA and there’s always a time lag with the FDA these days. And so it’s – but we need what they want us to get FDA to concurrence that our assay is fully validated and that’s what the time differences. “
Now let’s move to manufacturing……. He states “ Today, we remain on track to achieve manufacturing capacity of a 100 million doses per month, by the end of the third quarter of 2021 and 150 million doses per month by the end of the fourth quarter of 2021.” And he adds : “We expect our global supply chain to support expansion of distribution of NVX-CoV2373 beginning of the second half of 2021 and we anticipate shipping vaccine upon anticipated regulatory approvals . “
During Q&A , Mayank Mamtani asks “ are you able to comment on sort of what might be our monthly run rate say for July or anything on the doses that you may have stockpile or even like, the shelf life, because I think folks are concerned that this bureaucracy of getting – just getting into the market might be impacting what doses you may have already sitting on the shelf and not getting to people who can benefit from that.”
CEO Erck : “ Yes, I think we’re certainly working to make sure that we don’t run into a shelf life problem of product being made. We have been successful in extending dating from six months to nine months on a variety of our in process work. Our expectation is that’s not going to be an issue, we expect fairly rapid licensure, and we expect to be able to use the product we make that we’re scaling up right now. We’re scaling up globally to this rate of a 100 million doses by the end of next month. And so you can figure out what that rate is to get to that point from a 100 million to 150 million, but our – until the product is filled, we don’t have to worry about dating because the drug substance, the antigen itself is frozen. So that’s all on the shelf, we’ve got many tens of millions of doses that are already ready to go by the end of August, when we expect to begin shipping, being able to ship, we’ll have – globally, we’ll have probably over 100 million doses that we’re able to ship. So we’re cooking on that issue. I mean, it’s going well. “
_________________________________________________________________________
Dedicated to all true longs...
Now to Novavax....please take the time to read the following . I know it's long but I think you will find it revealing . My main findings were :
Novavax leadership clearly underestimated the changing Covid-19 environment and the response by the global regulatory authorities.
The establishment of the global production and sourcing proved more challenging than envisioned.
They appear to have miscalculated the focus of some of the regulatory authorities . They have hired the necessary talent to address this issue.
I think Novavax has worked very hard and made great strides to move to the market place under difficult and changing circumstances . Yes, all in the arena have but Novavax started with significantly less capital reserves.
The delay in reaching the market place has been very costly to themselves and people in need throughout the world. Obviously , GAVI, SII , SK bioscience , Takeda and the APAs with the EU , UK, Canada , Australia, New Zealand and Switzerland testify to the confidence and belief that Novavax vaccines will reach the arms of millions of people in need
The bottom line - Novavax vaccines are proven safe and effective. I believe Novavax has learned much over the past few months and thay will take that knowledge to move forward and reach the marketplace . So here we go .
_______________________________________________________________________________________
Let’s go back to some comments CEO Erck made during the “ Earnings “ Call held on August 5 , 2021 .
….. “ we filed regulatory submissions in multiple markets in partnership with Serum Institute. These regulatory submissions for emergency use authorization were filed with a Drugs Controller General of India and regulatory agencies in Indonesia, and the Philippines. We expect to file for emergency use listing to the World Health Organization in August . “
Now turning to the U S , “ we’re continuing to work with the FDA in collaboration with our team …. to finalize our filing package for authorization under emergency use authorization. The current timeline looks to now be in the fourth quarter, hopefully early in the fourth quarter. This timeline is based upon a couple of factors. “ He goes on to say - “First, the completion of validation of analytical methods and additionally, we have many complex critical activities as part of our finalization of our authorization submission that are being carried out with multiple third parties. Importantly, I believe all the key components are in place to achieve our filing within the fourth quarter. “
Now moving forward to other filings, CEO Erck states “ we continue to advance our program with the MHRA, which is the UK regulatory agency. We are targeting to submit to MHRA in the third quarter, but as with all applications, this may change based on discussions planned for later this month to support our planned application in the third quarter. Given that there are many countries who will rely on MHRA authorizations as a basis for their own regulatory approvals, this is another important global filing. “
Duirng Q&A :
Representative from Feffries asks…. “how much risk is there associated with addressing some of those last remaining issues that are the gating steps to those filings? “
CEO Erck responds : “Yes. I think the risk reduction is dramatic. I think that it’s a matter of now mechanics of getting all the data – final data assembled and submitted. And it’s – we’re talking weeks here, we’re not talking months. So I’m not worried about the future submissions. “
Mayank Mamtani with B. Riley FBR asks …. “the UK filing that seems to be taking a little longer than maybe that was anticipated. I’m just curious if the Com-COV2 data that is being worked upon also mix and match vaccine data. I’m just curious if you have an update on that and if that data set is playing any role with what is going on in UK. And if you can comment on the CMC side, the first part of that question would be helpful too. “
CEO Erck responds : …… “ So there are two studies that are being funded by the VTF and are being done by University of Oxford and Southampton. One of them has a heterologous vaccination study that you referenced, Com-COV2. And the other one is a boosting study where people receive two doses of other sponsors vaccines and are being boosted by our vaccine. And that’s the cough flu study. Those data – those studies are sponsored by ourselves or sponsored by the universities and we understand the data will be made available and published in the September time frame. …. We’ve discussed this data with the UK regulators and they suggested it would be helpful, but thought that our phase to boost data in conjunction with our South Africa data would really be a desirable to include it in a label indication.
Charles Duncan with Cantor Fitzgerald asks ….. “what is this specific question that you’re looking to get at MHRA or is it a checkup meeting prior to filing an application for or finishing the application for approval in the UK?
John Trizzino responds “ Yes. This we hope would be the final meeting where we’d have the submission after that. We’re looking at the final questions that they come up with and leading to a filing in
September. “
Eric Joseph with JPMorgan asks ….. “ can you speak to what extent the submission packages or requirements differ from those already submitted with a services to for India, Indonesia, and the Philippines. …… just curious to know whether you’re seeing European regulators move the goalposts at all, given that it’s kind of taking this long to complete those submissions. “
CEO Erck responds ….. On the regulatory issues, so every – so we have made products in different plants and use it in different clinical trials. And what is the only difference between what we’re filing with everybody else and what we’re intending to file with the MHRA and EMA is we’re finishing up some comparability work between loss that needs to be done. And those, I think the actual studies are done. And data as we put together and that’s what’s going to take, we gave you this data put together and submit it to the MHRA and so it’s – I have great deal of confidence that that package will go into them on the timetable we just talked about. “
Eric Joseph follows up with “How are you planning to update investors, I guess, as it relates to those package submissions…”
CEO Erck “Well, I think when – obviously when we get an approval, you’ll get a press release. And I think when we file with major agencies like MHRA and EMA, we’ll announce that in a press release. “
Eric Joseph follows with - “ I’m just trying to understand – a better understand some of the language in your most recent filing here, as it relates to your agreement with the U.S. government saying would like to see FDA alignment on your analytical methods before conducting additional U.S. manufacturing. It gives how to understand that those that suggest some kind of authorization for – before continued U.S. production. “
CEO Erck resonds : “Yes, that’s sort of the source of some of the delay with the FDA is we have this USG, the U.S. government that is our partner in developing this vaccine. And they are the gate to are submitting to the FDA. So there’s has to be some negotiation with U.S. government and does the validation activities, meet their standards. And then we take it to the FDA and there’s always a time lag with the FDA these days. And so it’s – but we need what they want us to get FDA to concurrence that our assay is fully validated and that’s what the time differences. “
Now let’s move to manufacturing……. He states “ Today, we remain on track to achieve manufacturing capacity of a 100 million doses per month, by the end of the third quarter of 2021 and 150 million doses per month by the end of the fourth quarter of 2021.” And he adds : “We expect our global supply chain to support expansion of distribution of NVX-CoV2373 beginning of the second half of 2021 and we anticipate shipping vaccine upon anticipated regulatory approvals . “
During Q&A , Mayank Mamtani asks “ are you able to comment on sort of what might be our monthly run rate say for July or anything on the doses that you may have stockpile or even like, the shelf life, because I think folks are concerned that this bureaucracy of getting – just getting into the market might be impacting what doses you may have already sitting on the shelf and not getting to people who can benefit from that.”
CEO Erck : “ Yes, I think we’re certainly working to make sure that we don’t run into a shelf life problem of product being made. We have been successful in extending dating from six months to nine months on a variety of our in process work. Our expectation is that’s not going to be an issue, we expect fairly rapid licensure, and we expect to be able to use the product we make that we’re scaling up right now. We’re scaling up globally to this rate of a 100 million doses by the end of next month. And so you can figure out what that rate is to get to that point from a 100 million to 150 million, but our – until the product is filled, we don’t have to worry about dating because the drug substance, the antigen itself is frozen. So that’s all on the shelf, we’ve got many tens of millions of doses that are already ready to go by the end of August, when we expect to begin shipping, being able to ship, we’ll have – globally, we’ll have probably over 100 million doses that we’re able to ship. So we’re cooking on that issue. I mean, it’s going well. “
_________________________________________________________________________
Dedicated to all true longs...