Teach, NVAX already know the mechanisms of protection confered by NVAX RSV vaccine. It's discussed in details in presentations, conferences and patents. They don't need anyone to explain it to them. We're about to start phase III. Do you know what this means? Either you're lost or you're being mischievous. Which is it?
Teach, telling NVAX about this research is like telling NASA how to invent the wheel. NVAX has already wrapped up the RSV vaccine over two years ago, formulation, manufacturing and dosage selection. We're about to start phase III with flying colors.
Or, just forget about the Ebola vaccine from Merck, and embrace the one from NVAX which has already completed all required optimizations and scale-up.
Wait until RSV elderly and then maternal results are out. The one year targets will then be close to $30
Link (just remove the stars):
Colkhat, probably analysts and investors were bugging Stan to confirm in clear terms that all strains passed everything and in addition to that, beat the comparator from big pharma. So, Stan did while remaining very brief. Yes, this tells me that he wants the details to be released in a major conference or in a major publication.
Colkhat, successful results do not necessarily imply beating the comparator. This is definitely additional info. It was most probably told to some writers or analysts during the weekend when the market was closed. Then, it was published early before pre-market started. So, everything is legal. I'm very excited about this. The results are now confirmed to be excellent, not simply good. That's what I've been hoping for for a long time. I was sure of good. I wasn't sure of excellent.
I agree with Lobster. I don't know what was wrong with me confusing fast-track with accelerated approval. I know very well the difference and the implication. I'm getting sloppy. Perhaps I should delete all my messages in this topic. Perhaps not.
Very good points, especially about NA. I've been waiting 8 years for NVAX to succeed in proving the importance of including NA in the flu VLP. It looks like they have done. I'm anxious to see the details.
That's good. The most important thing is to provide protection against Ebola, not make money from it. NVAX can still play a role. I never expected NVAX to get approval based on phase I alone.
"(4) RSV maternal, RSV elderly. Neither of these will get accelerated approval; human trials for efficacy are very doable in a one-year timeline."
True. That's what I've been saying for a long time. In my original message I somehow used fast-track and accelerated approval to mean the same thing. I wasn't thinking straight.
Regarding seasonal flu, it's not a big leap to give them FDA approval after only phase III safety & immunogenicity, and let them do phase III efficacy after approval.
Correction: H7N9 and RSV maternal received fast-track designations, not accelerated approval.
In this topic, it slipped my mind to distinguish between the two. Anyway, the general content of the message is still valid.
Google the following (they're very easy to understand):
* FDA fast-track
* FDA Accelerated Approval
* Emergency Use Authorization
Yes, of course. NVAX RSV vaccines work well without adjuvants. That simplifies greatly the approval process. However, as serious as RSV is, the FDA would not cut any corners at all. They will fast-track it or accelerate it, but not give it Emergency Use Authorization.