I like you. You are literary and write well. Stocks, especially biotech stocks, are stories. And typically they have several chapters. Hopefully DVAX is starting a new chapter. Now you have every right to question the veracity of this story. The company has a multiple of times said: we are encouraged, only to have the FDA drop a bomb on them. It's the old law school trick, watch what they do not what they say. The question you pose is: How can the company be encouraged when they were asked to provide a safety trial for everything. Why didn't the FDA grant them approval for CKD. It is a good point, and all I can say is that I understand the reasoning. The path forward now must be a straightforward one. No approval for a restricted population with an additional trial for the rest. One safety trial and you get the whole ball of wax. When you think about it, it makes sense. Questions of safety reflect on ALL populations. Moreover, if the safety trial, and we should know more about this in the coming weeks, is as I suspect, then the light won't be far inside the tunnel. It should not be more than 7,000 patients and a one year follow up. Statistically it is meaningless. But I think enrollment, vaccination and the start of the follow up can commence by fall next year. If the trial provides for interim analysis then the world will know what we all know, Heplisav is effective and safe and this will be known in as little as a years time. At 4 dollars I would say sell. At a buck I think it is a screaming buy. But I come to this from a different perspective.
First off, Thank You. Thank you for the kind words.
And I apologize about starting off in a "shoot first, questions later manner"; I wasn't really quite fair on my part; sorry for that.
Speaking only for myself here, I'm stymied by what happened. It has just been such a horrendous reversal of fortune to be where we are now from where we all were back in only 2011 and where Dynavax (under Dino Dina, Tyler Martin, etc. etc) suggested that we were headed (much bigger and better things).
Even a month later it's still a shock for me and the list of who's to blame, and who cannot be trusted, just seems to grow without end and everyone is on it. I didn't grow up during "McCarthyism" but it kind of feels like it. Everyone's a suspect and you see a commie everywhere.
It's too much emotion and I realize that is not the correct approach.
I've traded in and out of DVAX numerous times and up to April of 2012 I was ahead on it and doing decently enough. At $1.10, I'm about 80% down from where I last bought ($5.28 per share in March or April of 2012).
It's horrible, but everytime I buy a cup of Cumberland farms hot coffee, I think, "well, there is one share of Dynavax ($1.06).
This SHOULD NOT HAVE HAPPENED.
The long shareholders of Dynavax got mugged; and I mean MUGGED.
At the worst case, Heplisav SHOULD have been "risk appropriate" for the Chronic Kidney Disease populace.
According to Dynavax, the FDA expressed it (years ago) and then went back on their word 18 days ago.
We never seem to hear directly from the FDA themselves (VRBPAC would be an exception); we only hear what the company says that they were told by the FDA. So who's telling the truth and who isn't? That's why (in my view) they are both on the "list".
Right now, I'm wary of what the company is saying.
A whole bunch of investors (with A LOT more at stake than me) just got "swamped" out of this thing.
Investors like Kaufman; and that's why all of the class action lawyers.
Dynavax is looking for new investors (to replaced the ones that just got washed out), they are looking for new $$$.
What WON"T they say to draw new investment money in???
On June 11th (the day after they dropped the bomb) they had a representative giving a presentation on Heplisav to potential investors.
Old $$$ played out, bring new $$$ in.
Promises of future success are great (kept within "safe harbor" limits), trials and trial results are great, market calculations and statistics are great.
But someone(s) isn't playing "straight" here and a WHOLE bunch of people just got roasted in the epilogue. And the company doesn't seem to miss a beat, they just go right on to the next thing (a new trial, new negotiations with the FDA that never speaks, new shelf offerings.....)
For me, I'm stuck. I can either take my measley 20% and walk or I have to stick it out and see what develops. 2-3 years is a big thing (in terms of waste), if it ends the same way that it ended 18 days ago. And GSK and Engerix-B are the only current winners from the events of last November until June 10.
Earle Grey is a wild card, and I'm betting that he is here to come down on GSK's side.
He will most likely go with another Heplisav trial to ensure that Engerix-B sells for another 3 years.
To me, that is not in the best interest of Dynavax.
But I don't seem to see too many people who are actually interested in or working for whats best for Dynavax (for sure, NOT Dino Dina or the BOD). The shareholders MIGHT be the only ones (maybe).
The TLR9 science (in general) were VALIDATED by the presence and partnerships of Merck, GSK and AstraZeneca. They wouldn't be here (or have been here) if it weren't genuine.
But again, someone isn't playing "straight" here.
I say sideline Heplisav and advance the development of one of the GSK programs. See if the FDA dares deny that. Make one of those 4 a product, then negotiate some deal over Heplisav.
But I'm not the one running the company; now am I ?