Interesting line of thought, birdy. But I don't think an ex-NA go-it-alone strategy works. We need that partner. We need that cash. But does Pfizer or Merck now make more sense? AZ and GSK might now have a more difficult ROI calculation. (Even Sanofi - meh)
The hospitalization cost per infant is higher than the per adult hospitalization cost. But the number of infected adults is much higher.
Then you have outpatient medical costs.
Then you add into both columns the biggie: the economic cost of lost production when a parent, son or daughter, spouse or the patient themselves can't go to work.
From approximating the costs to society of alcoholism or drug abuse to the costs of cancer or infectious disease, the lost productivity cost is almost always the largest number and is taken very seriously by the policy-makers.
I imagine all the thumbs down on your insider trading remark are only because it is old news and has been discussed ad nauseum. Since your blinders are off, perhaps you could remind the board who sold and how many shares and options they have left.
You're new to the board. Let me Give you one tip. I've had all oubra ids on ignore for a long time, the first since August. Discussions about TA with them will only drive you crazy.
My guess here is that, other than cutting edge engineering in this field, the only real moat NVAX will have with its flu vaccine is it's ability to pair itself with the only RSV vaccine. Not that this isn't huge - it is - but I get the sense there are other companies working on the same thing right now. I'd love to hear NVAX claim some crucial patent here but it doesn't really matter if RSV is a success.
Lobster: "Universal refers to a common epitope found on all strains. It is not multivalent it is a single conserved antigen approach that would serve all strains"
The presentation suggests they have found an epitope (some epitopes) common to Group 1 as well as separate epitopes common to Group 2. [Group1: H1,H2,H5,H6,H11,H13,H16,H8,H9,H12] [Group2: H3,H4,H14,H7,H10,H15] The poster, Biopro, suggested NA antigens could still be included in a vaccine. Of course, there would be Influenza B antigens as well.
So the dream vaccine might contain just two antigens to cover Groups 1&2 of Influenza A and be long lasting but it seems no one is close to that paradigm shifting flu-vax.
Just guessing, of course, but it sounds to me like these more universal antigens are still likely to be part of an annual vaccine. I imagine an NP vaccine with multiple antigens given annually still. Perhaps FluA Group1 and FluA Group2 that do not have to change much year to year, one or two Group B antigens, another NA antigen and the RSV antigen. If they can get broad coverage with less, then they would do it. But there is less drift with NA and B and having the two FluA HA antigens create a more "broadly neutralizing" response helps NVAX efficiency and can give, presumably, better annual coverage.
I love reading this kind of detail. Thanks.
Regarding EM, is a machine standard in a vaccine lab? Or do they go into another's lab when needed?
I understand your effort at more precise language but sterically constrained is what I imagined you to mean.
It might be a bit much to expect from NVAX, but a comparison of VLP induced immune responses to the NP responses, in terms of strength would be nice. VLPs have some cell wall that might boost response. The "clean" NP seems much more likely to need an adjuvant.
I would love a discussion of what adjuvant issues might need to be addressed in the upcoming flu trials if, indeed, MXM is required. I would anticipate an increase in local reactions with MxM use. I might expect additional trials needed to show the adjuvant in the new combo vaccine doesn't increase side effects from other vaccines given concomitantly; or a black box warning to use the combo vaccine at least a week or two from, say, Tdap, or Prevnar. I don't know the data, but in my practice, I seem to see a lot more severe local reactions to Prevnar if given on the same day as a flu shot in the other arm. The flu shot seems to potentiate Prevnar side effects. A known adjuvant could have an effect on more than just the vaccine it was formulated with.
Adjuvants are one of the boogie men the anti-vaccine crowd loves to fear. If NP vaccines require them, the road to combo vax might be a bit longer.
For those who don't clearly understand where I'm coming from with these questions, they do not imply that NVAX has no answers. I'm sure they do. I have every confidence that this group of scientists are on the cutting edge of vaccine technology. I simply want to understand better.
Is there something about the NP technology that allows for the use of these "universal" antigens that the VLP technology lacks? I think MuddyC speculated that perhaps the lipid bi-layer in the VLP got in the way of full antigen exposure. Perhaps. But from what is presented, I don't see any explanation why the reverse engineering of antigens that are "broadly neutralizing" by the methodology they describe wouldn't fit in with VLP.
It seems there are two technological departures from the old NVAX flu vaccine whose link is not clearly explained (at least to me). The use of NPs instead of VLPs has advantages in yield, flexibility, fit with RSV and lack of royalties, as outlined by muddy, lobster, biopro and Dr Fries. That is clear. But how, exactly does NP technology advance the goal of a more universal flu vaccine? (and, correlated, what technology does NVAX own, IPwise, or do better than all others, so that their competitive moat is wide?)
-Perhaps the NPs allow for better antigen presentation and thus better immunogenicity.
-Perhaps the NPs allow for multiple antigens on a single particle. I assume each VLP would only contain one antigen and a pentavalent vaccine would simply be a mix of four flu VLPs and one RSV NP. Do they not formulate well together? Storage issues?
-Could NPs be made with many more than four antigens? Could NVAX come out with a vaccine that uses more than one antigen for each HA subtype? Is there an advantage here?
-Does NVAX suggest they might develop a flu vaccine (or combo) that would not require re-engineering every year? Or does the process they outline on slide 17 have to be repeated annually? Or would it simply be easier to mix and match antigens that they already had on file at the beginning of every season?
-How does the GE technology fit into the new NP technology? Are their business reasons here also for the switch from VLP tech?
I think answers to some of the above would help marathonman and others believe in manag
that should read 'greater than' 2 mos
YMB has trouble with that sign
- don't think so -
I feel pretty good right now. I like backing winners.
This is a winner move.
And my Warriors are about to play the Cavs :-)
Yes, but going away from the VLP flu, for which there is great ph2 data, will cause a delay.
I don't really care because, as we have discussed, its all about RSV this year and the eventual flu product should be best in class or it isn't worth doing.
That would be a great line of questioning if you are on the call.
I wouldn't mind also knowing if there is any data on the maternal ph2 ab levels at 2mos and any resp sxs data on the same cohort. thanks.
PR is exciting stuff. Will look over the presentation tonight. One small word of caution, the addition of the MM adjuvant adds come complexity in terms of possible increase in allergic reactions, side effects, and regulatory delay. Don't get me wrong, this redirection is like shooting the moon and cool, but the combo finish line is now more distant.
Mike's right. The option action you see is the tip of a huge shadow market iceberg you can't make sense of. On the surface, someone hedged a few hundred thousand shares at $3.35 (4.50 - 1.15). Every day volume is more than 20 x that so this is a drop in the bucket. And with a binary event on the horizon, it makes sense for some to hedge. This options trade is a non-event.
- less than 5%
After his sale, not only does he own 4,000 shares indirectly each for Casey and Dustin Evans (presumably family), he now still owns 340,977 shares directly and on 12/31/15, per the Annual Report, had options for another 305,000 shares. Last year, in June '15, Mr, Evans was awarded 40,000 of those options at the ASM (exercise price $8.94), I would expect another similar award for him next week.
How much is enough?