Not much to elaborate. Assume we're where we are, 18. Then bases on my little off-the-cuff guess, that'd mean up to $25 inter-day and in follow-on days a sustained price $20.50ish.
Indeed. Positive seems very likely at this juncture, and should propel the stock substantially IMO. I figure more-or-less on a MAX inter-day upswing of 5-7.50, with a sustained gain of 2.50ish.
I did some looking and encountered several PDFs from GSK on Cervarix.
BLA was based on:
HPV-008, an efficacy study that enrolled 18665 (1:1)
HPV-013, a 3-4 year safety study that enrolled 2067 (1:1)
Counting up enrollment of all studies, I got enrollment: 33594
Considering the basis of the successful BLA was a population of (18665 + 2067 ) / 2 = 10366 that received Cerverix, then my conclusion based on the BLA is that Heplisav is in-line with "approvable on safety" based on the post HB-23 pooled total enrollment around 13,000. Great (hopefully)!
Excellent discussion, thx for your inquisitiveness and input.
"The mITT population consisted of 1789 HEPLISAV subjects and 603 Engerix-B subjects for DV2-HBV-10, and 1947 HEPLISAV subjects and 476 Engerix-B subjects for DV2-HBV-16. In the pooled mITT population there were 3736 HEPLISAV subjects and 1079 Engerix-B subjects (Table 3)."
Pooled population post HBV-23 will be roughly 3736+1079+8000=12815.
12815 exceeds the suggested pooled 10000 minimum in this article. A "consideration" however is that the vaccine under discussion here, Heplisav, includes a novel and more potent adjuvant in its formulation.
I hear you Jack. To clarify (correct me if I'm wrong) I think there were 2 NO votes who commented that IF it were allowable to vote YES based on the company promise of a follow-on 30,000 subject P4, then their vote would be YES. However I think they said the rules required their vote on safety given the data currently at hand, and based in the currently available data they voted NO.
So the question is: assuming these 2 individuals are still on the committee, does the currently available data next time around satisfy them that the vaccine is safe. Because as before they will vote based on currently available data and not any promised follow-on trials. Do I have that right by your reckoning?
If so, then the question is: are they satisfied by by the previous database plus the latest 8000 subject trial. Does that also sound right by your reckoning?
We already know the vast majority of the FDA panel feels that Heplisav is safe. 5-8 against on safety doesn't strike me as a vast majority, but then I am terrible at math. Perhaps you can assist on the math?
Really? "Jabbing each other in the dark on this topic" resulted in OJ's post "Evaluation of New Vaccines: How Much Safety Data?" I'd call that a nice little piece of research and a little beacon of light. Or do you think that info still leaves us just as much in the dark?
Excellent post. Sure wish we had been aware of this topic pre-VRBPAC last time around! Posts like this,if I may complement, are precisely the value that message boards can provide. Exposing to us retail weenies info that the institutions are , and have been all along, aware of.
OMG, as this boards leader your obsession with me gives me chills and shivers all over Jdoob. I sit here like Buffalo Bill exalting over what has appeared in my virtual dank cellar.
What you call a vice -- calling out bshyters -- I call a virtue. Thus you are no peep, your are our leader and "The Oracle of Berkeley".
Great point as always, if one had uncertainties, why would they invest a dollar, or for that matter even a single penny in a company. Uncertainty has NO PLACE in investing, you are right.
You are right too that I'm a bagholder, but as you succinctly point out, that's part of investing. Bagholding YES, uncertainty NO.
As this stock rises, right on, it bothers me. Why can't it just go to zero so my bagholding suffering can end and I can move on to a new bag to hold. Indeed, were there were a stock with ticker JDOOB, I'd move on and deliriously "hold the bag". As you say, that's too bad but expected.
They say the cream will always rise to the top.
They say that good people are always first to drop.
What of Dino Dina, will his presence still remain?
Remember Tyler Martin, ever saintly in a way.
Where are you now?
Where are you now?
Where are you now, I said,
Where are you now?
And therein lies the rub, back then we had pretty decent dialog on this msg board; nevertheless we missed the now OBVIOUS -- that the total size of the Heplisav database was 1/2 that of vaccines that got approved, and those likely not having a novel adjuvant.
The rub I should say, that this board is now permeated by "yes men", thumbs down to dialog not aligned with "DVAX to the moon" and approval a shoe-in. This board no longer a place where one might have the chance of detecting negative factors. With the exception of only a couple posters, this msg board has turned to utter #$%$, uncritical repetition of company PRs at best which is useless, anyone can read and rah rah the PRs, who needs them repeated.
Long live Isaac, thumbs up baby!
OMG, quintuple THUMBS DOWN to this one!!!
And Jack needs to share the love. Thus my thread "Looks like Heplisav is a shoe-in for approval", looking for many many thumbs up!
The one I found interesting (again seems quite possible but who knows) was the manufacturing head. According to that witness, he replaced a series of fired employees and says he was fired day after insisting there was still time to alter the BLA for a REQUIRED piece of the manufacturing data that has to do with key measurements to keep the biologic within tolerances like temperature. Search for Stephen Tuck. According to this witness, DVAX knew there were issues in the BLA concerning manufacturing and indeed negative manufacturing comments cropped up in both the US and EMEA reviews if I recall correctly.
I mostly found it interesting as a peek inside a little company. While from the outside we'd imagine all is COMPLETELY on the up-and-up especially considering the ENORMOUS amounts of salary and options, that's not reality. Obviously this was the Dynavax story; other variations on that theme play out elsewhere. Having long ago been in CTIC, obviously I know some outfits are run by virtual crooks and DVAX shines in comparison.
Hopefully it's neither here nor there for this time around, although Gray obviously is a seasoned and sharp cookie, he surely either gave it a read or knows of the contents. Thus my estimation that likely Gray showed Martin the exit door. 'Cause as I mentioned, I had a very high opinion of Martin.
In summary, just interesting stuff. Now, may the thumbs down cascade upon me, OMG mentioning what might be perceived as NOT A POSITIVE, how dare I!!!