...I'm not sure the stock will do any better this year, and I'll tell you why.
The results of RSV for young women will be great, but this does not guarantee success with babies, or with newborns (acquired from mom). Further studies are needed for this.
The results of RSV/Flu might come out mediocre. There is no garantee they will be good. If they came mediocre, the odds for good results with babies go down.
Optimization of B/Brisbane and/or manufacturing process might not conclude this year.
If all the above occured, and they could, PATH the stock might not do any better than it's doing right now. So, let's not quit our jobs yet. Wait and see.
Serenity Now. Insanity Later.
I have to agree here with Lou. Based on the phase 1 trial I am strongly inclined to say that the phase II in women of childbearing age should produce similar results. Unfortunately the market for an RSV vaccine is not healthy adults between the ages of 18 and 45. While this trial will open the door to a trial in pregnant women (which may take a loooong time to enroll, BTW), I don't think it will be a major driver of the PPS or entice an immediate partnership. Therefore, while I do think we will get a pop from a positive trial results for this P2 trial, the real wild card is the elderly trial. Since the elderly population is a target group for a RSV vaccine, a positive outcome in this trial is pivital towards a commercialization strategy. As most of us know, and as demonstrated with flu vaccines, the immune system of the elderly does not work nearly as well as a young adult, therefore a good clinical result for RSV is by no means a slam dunk. I am pinning my hopes on the adjuvated high dose RSV VLP exhibiting sufficient efficacy in anti-F protein antibody titer and seroprotection in elderly. This coupled with minimum flu protection is most likely the best outcome of the P1 elderly trial. That is just my hunch, and I think that result will be good enough to really turn some big pharma heads, and move the PPS northward...
Thanks for weighing in. It's good to hear from a PhD in the field.
To be clear, I'm not saying the RSV/Flu results will be mediocre. I said they could be, which means I believe they could also come out good. The adjuvanted arm will definitely be much better than the unadjuvanted. However, The unadjuvanted might come out sufficiently good.
I say this because the unadjuvanted group in RSV phase I for young adults produced 5 times the amount of F Site II antibodies associated with adequate protection (based on Palivizumab data). So, if the elderly produced 5 times less antibodies than did young adults, the elderly would be just as protected with NVAX RSV vaccine as they would be with a Synagis treatment (theoretically).
Bottom line, we don't know yet. We have to wait for the results.
I am also pinning my hopes on a adjuvanted high dose RSV f-protein vaccine for the elderly. The adjuvant is the key, in my opinion.
And we need a significant PATH partnership to accelerate the maternal RSV program. I've said it all along. No one can really get a RSV vaccine without the support of PATH. I believe the trials will need PATH's support and reputation. I also think the enrollment will also take a long time if Novavax was by themselves. But if NVAX partners with PATH on the next trial, then PATH can throw their weight on recruitment to the trials and also have centers in developing nations which should accelerate the enrollemtn exponentially. Unless the patients are challenged with RSV directly, they would need a very large sample size to figure out if the vaccine works. Novavax needs to work closely with PATH to leverage what their reach.
great analysis, recsbrugby... a good result from the maternal is expected...and together with a decent result from the elderly, pharmas will be more inclined to partner in the next range of trials.
question... will the tweaked B Brisbane be tested on its own before the next quad trial? Might they test the tweaked B against the old B in the same trial... ? sans the other three vaccines...
"The results of RSV/Flu might come out mediocre. There is no garantee they will be good. If they came mediocre, the odds for good results with babies go down."
The results of RSV/Flu for the elderly might come out mediocre. There is no garantee they will be good. If they came mediocre, the odds for RSV good results with babies go down.
"If all the above occured, and they could, PATH the stock might not do any better than it's doing right now. So, let's not quit our jobs yet. Wait and see."
If all the above occured, and they could, the stock might not do any better than it's doing right now. So, let's not quit our jobs yet. Wait and see.