Waiting for the webcast replay to post so I can hear the 12:15-ish comments from Ostrach. When asked about the trial size and cost, he replied in summary: "We will explore all options for the capitalization of Heplisav" -- Does that mean a partner? Sale?
The trial requirement comments were phenomenal! Small study, short time frame... go go go!
EU on track!
If you did not hear the presentation, get on over to the Dynavax website and hit PLAY, when it posts!
Ostrach indicated that the standard of care follow up would not be necessary. This would SIGNIFICANTLY shorten the study time and cost! We could be talking about a 3 month study based on Heplisav's immunogenicity response.
This could cut study cost by tens of millions!
This is the big leagues Raven! Dynavax is not complaining, they are moving forward WITH a plan! They are taking action!
I think he means small wrt the 10-30k trial size that many have been assuming. While anything 10k might be considered a worst case scenario, investors and Wall St seem to have presumed nothing but worst case scenarios is all we can expect from DVAX (which lately has been true), so that may be why the stock is still up after the news. And if cost is only to be about $30m and not run comparative to GSK's vaccine, those are also better than expexcted developments.
It was estimated that the study size would be between 10,000 all the way up to 30,000 which caused the sell off in June.
The 5000-7000 study size is easily acheived for the FDA approval process with the current cash DVAX has. So they will not have to dilute their share value to reach the FDA's goals.
The stock was beat down on the fear that they would go bankrupt performing the 30,000 person study. Keep in mind that the next study is just going to be aimed towards safety and not effectivness becasue that has already been proven so it will not be as expensive to perform