I4, one can reconcile this:
1) On the very quick start of Phase 1 and scaling up production Q 1 next year; this may be under BARDA (with P 1 under the FDA, with BARDA's support).
2) On late next year for a P 2. This of course seems inconsistent with scaling up production early next year. But, BARDA has authority for the scale up of production, but not Trial phases, so the P 2 trial under the FDA may come later than the BARDA scale up.
Rez, I would not do that. I generally avoid thumbs anything. Heck I don't think I could every run a marathon, did a couple 12 milers and felt my body would not handle much longer. 10 miles in 1:04 my best, now I'm just happy to be able to walk to the car.
Do you care? If they did file a request, it is not a material event and needs no reporting. Fast track for this looked possible quite some time ago -- I recall distinctly the company indicating the possibility of BARDA stockpiling NVAX vaccine in 2015 (possibility). As I and others here have noted, Ebola scare raised the possibility. I actually posted yesterday, before the PR, that we should see news on H7N9 pretty soon and that some sort of expedited approval process may happen.
The NVAX Ebola is getting even faster treatment, and it may also get fast tracked. BARDA has a mechanism (emergency use) that is faster, and so fast track by the FDA is not necessary -- but I give it better than 50/50 a fast track here.
Finally, although the nuances are impossible without a martini, I believe NVAX will get fast tracked it's RSV vaccine (though not for pregnant women).
I have wondered whether large shorts have an option to buy shares. Not from NVAX, but from institutional holders. If the short position rises in this period (we won't see data for a couple weeks), I will be sure of it. If so, when this is completed, trading should change quite a bit. A hold and then a narrow range might be intention to keep day and swing traders away.
If the company would nod they are considering options for shareholder value and would consider merge or a buyout, this pps would pop $2-$3. I actually believe this is going to happen, but not real soon; I also believe this will happen AFTER these funds get done tinkering with the stock.
Well, that 11:45 was pulled out of his butt. The sell side looks pretty solid, so far, and unless Stooka201 is working for these large traders, he's no clue on it.
We either have some institutional lightening or we have institutional entities assisting in the accumulation (which might be short covering). 23 million shares 3 days ago, 11 million 2 days ago, 5 million yesterday -- good volume which was diminishing nicely, I would have liked to see 2 more days and the volume dropping below 3 million -- anyway, today the buyers look at the charts and see "wow, some willing sellers in the range the last 3 days, so let's not get hasty," and that is what we are looking at.
I like our prospects even today, but I'm not holding my breath. Sell side needs to slow and then we might see the buyside pick the stock up.
Well, that is because Dave is out right now and is looking to buy. So is Jeffgman69, it quite sad to see him bash as much as he can and frantically try to figure out a buy strategy (maybe he had that 10k bid in at 5.72 pre-market!).
Yes, sometimes you can tell when the pros are leading the AH markets, small blocks used to move the price in a direction and then they pick up larger blocks cheaper (if they are buying), or when they move it up with small blocks, the larger blocks they sell. Not a lot of volume yet in pre-market here today -- I've not looked at the separate trades, but it seem quite odd trading down rather than up with news this good.
That high concern is the final piece that most probably assures (1) a stockpile contract and (2) accelerated approval.
For those who don't know, accelerated approval is the fasted fast track, where a drug is allowed to go to market without the full phase 3 safety study (safety is studied post marketing, it is not ignored). Second, a BARDA stockpile contract is separate from accelerated approval, and they are not tied together from a regulatory perspective (you can get one without the other).
On Monday, after the presentations, I noted this would be a multi-day move; that the stock might backfill. And it did, with some good solid trading yesterday. I know some TA persons here believe it is TA driven, I believe it is TA guided but driven by the short positions and friends (this may include JPMorgan, Wedbush). I would have liked to see at least two more days of trading before this fast track news (accumulation with an up trend should have started today without the fast track news).
In any event, this should be a multi-day event (again). The crescendo play will be when NVAX announces funding for the Ebola initiative and definitive date for human trials (perhaps with animal results in, too).
It is going to be a good next month. If you are long. I have a prelim target, my own, suffice to say it is quite a bit higher. For you traders, outguessing these large players might be a hazard.
1. You'll find out that the process can vary;
2. You can actually learn something. Really knowing something is not all that traumatic.
medley, the NVAX Ebola vaccine has not gotten fast track (or accelerated) protocol from the FDA -- they just presented the data this week! However, as you noted, they are fast tracking for Ebola (this is the first bit of info) and NVAX has set out a schedule that is actually faster than FDA fast tracking (human trials in December, less than 2 months after the first data is released; NVAX statement of expecting to scale up production in Q1 of 2015, these are faster than any normal fast track).
Now, it is my judgment (and this the caveat if you need one) that NVAX did not outline its Ebola vaccine development program in a Press Release without tacit approval of the necessary authorities. (oh, there is another avenue for speedy development under emergency use authorization which is not an FDA call, but a BARDA call, and this might be used)
In any event, the NVAX PR lays out a lighting speed path for the initial trial, and the scaling up of production is actually faster than the FDA would allow even under its regular Fast Track or other expedited protocols.
Probably not enough shares for sale unless they keep raising the price.
If you feel lucky, you can sell some shares AH -- but if you buy em back tomorrow they might be more expensive.
medley, we have already answered that question. The NVAX ebola vaccine path is already faster than Fast Track. (Do you know FDA trial protocols, if so, the conclusion I and a couple others here reached is obvious).
freerobert33, it has been my judgment that they are likely to get fast track followed by accelerated approval, although the accelerated approval may depend on what H7N9 does. Even if they do not get accelerated approval (where final efficacy study comes post approval), it is my strong judgment they will get a stockpile contract.
THEY EVEN MENTION ACCELERATED APPROVAL POSSIBLE UNDER FAST TRACK -- AS I AND OTHERS HAVE NOTED, ACCELERATE APPROVAL IS THE BEST OF WORLDS.
You for one cannot be shocked by a finding that some can carry Ebola with no symptoms.
On the matter of public panic, what kind of actions would you recommend? I do think certain info should have been provide upfront, like the 21 days will capture 95% of the cases, and this means that some may get Ebola for a period after 21 days (it is a declining function, I'd say another week where there is some possibility but it is much lower, or if you complain, I'll use 2 weeks). This is not easy stuff.
You got two up thumbs for that piece of trash message, so far. There are so many errors in it, but I'm done tinkering. It is sufficient to say that if I mis-represented what you've said, it is because you've apparently had an idea or point to make but did not craft it well.
I already made my own conclusion that the 50% reduction of any evidence of infection in the vaccine group versus placebo cases is a significant finding. There no firm rule on these parameters, none, and the one rule that holds is that "good" results often concluded when comparing competing therapies. It varies with the type of virus, indeed flu vaccine results are hard to compare because of differences in study design, etc. Here, we are talking about a change in infection found that (lowered 50%) that compares well with flu vaccines where they've had decades of experience, here's a recent study (and you have to do some inferring, as cross study data is hard enough even for the same virus):
Email NVAX and ask em. As for me being smarter, I really don't know, but I'm pretty good at this stuff, it has to do with experience and persistence, not pure smarts.