CTIC: FDA does not allow superiority claims for products approved on surrogate endpoints (e.g. seroprotection). In light of that, I think the strategy of non-inferiority, with superiority if non-inferiority is met, is the best way to go.
As you well know Raven, Heplisav will, yet again, prove superior in terms of efficacy. Safety is the potential issue.
Reminds me again of the question I've posed before, why not run a superiority trial, seems like that would hold more water w/ committee & FDA. Not that they don't see superiority in the data, but to reject a compound demonstrated superior, who knows, even Dr. Doom might give second thought to that.
The risk with the HEPLISAV trial isn't inferiority, it's AEs.
However, I do agree, phase III success does not guarantee commercial success.
I present for your examination...... ......EXEL
Down over 50% today thusfar; another PIII trial fail.
They already have an approved product as well, but $1.80-$1.95 just the same.
The PIII trial went to completion, but failed to show increased appreciable longevity for prostate cancer suffers.
See there kiddies? Even when the PIII trial completes as per, it just goes to show that things can CERTAINLY still go wrong. DVAX's turn at the French sliding knife is getting closer......... ;-)
I'll see your Thompson Reuters upgrade (confirmed) and I will match it with a McLean from August 9th (see below).
McLean Capital Management resumes coverage for DYNAVAX TECHNOLOGIES CORP with SELL recommendation.BY Investars Analyst Actions - public
— 7:47 PM ET 08/09/2014
On August 8, 2014 McLean Capital Management resumed coverage for DYNAVAX TECHNOLOGIES CORP (DVAX
DVAX DYNAVAX TECHNOLOGIES CORP
Change -0.005 (-0.35%)
AS OF 10:17 AM ET 09/02/14.
Chart for DVAX
) with a SELL recommendation.
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Technical Recap on Biotech Equities -- CytRx, AVEO Pharma, Mast Therapeutics, Immunomedics, and Dynavax Technologies
PR Newswire - 9:00 AM ET 08/08/2014
2nd Quarter 2014 Dynavax Technologies Corp Earnings Release
Thomson Reuters Street Events - 9:21 AM ET 08/07/2014
Dynavax 2Q Loss $24.8M DVAX
DJ Realtime News - 6:00 AM ET 08/07/2014
Thanks for clarifying. In my original reply to you I should have also asked what ITYS means. I view the 25K share purchase as a positive indicator as well. However, it does seem like a somewhat weak indicator. Considering Grey's salary, I would have expected stronger confidence. Such a small purchase can almost be perceive as a means of sparking exactly the type of conversation started in this message thread, without having to come out and publicly come forward with any comments whatsoever, positive or negative. In a sense, it's a means of buying more patience and optimism from investors for a mere $37,250.00 It's a small amount of money relative to how much he makes, his position in the company and the market capitalization. In fact, it almost looks like he's taking one for the rest of the team, like a leader should. Do we see other executives filing in right behind Grey to purchase shares? Sorry to sound negative. I really try to be an optimist, but can't help be a realist when it's my money at stake.
Nevertheless, I continue to view DVAX as a Hold. All who read this post: I'm not an analyst, please do your own due diligence.
I'm a Perma-Bull
The CODE was sent out by Grey with a 25K Buy
With no SAE DVAX will start a steady move up soon
The Shorts that are gonna cover are running Short on TIME
And those wanting to get in or add are buying the "manipulated" dips
Take a look at the daily historical prices from
Nov 1 011 Thru Nov 1 012, Leading up to our date with Daum.
My best " Guess " OCT we start the move
You can Bet the Invested Institutions will AID the move
Just My Take, Think For Yourself *
I mean no disrespect, but can you elaborate on what you're trying to say? I don't understand. What are you talking about when you mention 25,000? I assume 25K shares but, without knowing anything more, I have no idea what you're talking about. Also, up until recently, you seemed bullish, are you now bearish? If so, what changed your mind? I respect your thoughts on DVAX. You've had many intelligent things to say on this board. I'm just perplexed by what you're saying in this message. Are you suggesting that Shorts will gain the advantage with the thought that individual or institutional investors will sell? Please clarify all of what you said above.
25k @1.49 is CODE Not investment
Heads up YOU Listening ?
Grey is talking to ya
As Rave said he's sucking you in, Or he's telling you the water is fine
Sellers are the Short mans Tool at this point
Same trade over and over
Good luck and as always don't listen to anything I have to say Think for yourself!
i would say that the raven is grasping at a bash on this thread. Pretty moot to the point of idiocy
It will take a lot of patience but the science will win out.
The FDA *was* convinced (I assume you're familiar with the briefing docs?) but the process was undermined by a single person with an agenda.
In the end today's SP will look ridiculously cheap.