Despite the company's incessant assertions to the contrary, it is clear the FDA does not want Heplisav. They have frustrated the company at every turn. The company said back in June that in a few weeks the protocol for the new trial would be set. It has been 3 months. Each month the company burns through more and more cash and still no word on the trial and the number of patients and the protocol. Per the company's statement you are looking at about 3 years before the trial once commenced would be completed. Their patents by this time will have only a few years left. Now they put out some release on their asthma drug which is so far away it is essentially meaningless. The question is when will they raise money again ... I think it goes sub 1 in the next week on capitulation selling as this story is just so old and tired.
Yes. I said the same sorts of things only weeks ago out of absolutely flaming frustration with those same June developments.
The EASIEST thing that the FDA could have said on Heplisav was "yes". Yes to the CKD populace (age 40 and up). But they didn't. We all know how it worked out.
Instead of going with the entire database of safety and efficacy data which Dynavax built up, brick by agonizing brick, the FDA went with the hair-brained ramblings of one man about, "a lack of varied ethnicity testing" in the database. How could anyone forget.
I cannot refute your point, when you step back from all of the "SAE holds" and "18 months of delays" and "years of further testing" and on and on, it's hard to argue that the FDA really DOES seem to want Heplisav. I cannot explain that away either, and it's hard to swallow as well.
No matter how you slice it, as long as there is a Daum in the works and an un-agreed upon deal between GSK and Dynavax, there will always be an unapproved Heplisav. Or at least that is the way it seems.
Daum's involvement does indeed show that our fabulous FDA doesn't seem to have clean hands in their dealing with Heplisav though.
Pay for play, pay for play.
Daum is GSK's boy, and they used him like the veritable tool which he is.
It's honestly smart policy by GSK, as much as I hate GSK, I have to admit that.
Dynavax may indeed have to sacrifice Heplisav, which I something I ranted about last summer.
But the company SHOULD try to get something for it. Don't chase the FDA and blow more money on unguaranteed prospects with Heplisav; make a deal for it and move on to something more attainable.
Or shelve it and move on to something less controversial and more attainable. Either way.
I don't know where or why the stock goes in the short term here. Maybe you are right, maybe you're not, who knows But there are too many big players involved here to say that the company and the science etc are just some big scam.
"But there are too many big players involved here to say that the company and the science etc are just some big scam"
Funny you mention that. If you recall last October (a year ago...) Cramer was really big on DVAX. They had big expectations and I think they too got blindsided or 'DAUMed' pretty hard. I know Cramer being involved tells me there is a lot more going on in the background that they lead us to believe otherwise. I don't know... I am honestly disappointed about not seeing the FDA response simply because I was counting on THAT being the catalyst.. Everything else is just chicken S and BS at this point. What matters IS the FDA feedback.
"The company said back in June that in a few weeks the protocol for the new trial would be set." That's how I recall it as well... I set myself a deadline and will sell regardless of what happens. At the end of October or just after their earnings I will sell.
I wonder why?:) could dvax ask for the FDA for patent extension? ...right now dvax only care about the restricted approval that's why eddy voluntary did the additional 2 secondary phase 3 trials. The conclusion of this current trials have been successful. Thus, they are moving on with the next product in their pipeline. i hope this novel asthma is successful because I have asthma and I am sick of the environment triggering my asthma and ruining my life style:)