Capt mentioned that Daum's co-administration point was a valid one. And my untrained mind now wonders, what might be the effect of Heplisav's novel TLR9 adjuvant when in the mix with other vaccines.
Also note there was one SAE in the recent trial; it was decided the SAE was related to the OTHER vaccine the person had received in same time period ... that "coincidence" probably caught some attention.
That would weave into the FDAs new 30,000 number, give us about 15,000
That would weave into the FDAs new 30,000 number, give us about 15,000 solo recipients and 15,000 co-admins. ~15,000 seems like a common # recipients if you look at other NEW formulations. And as this is "only" improving an already well-served market, FDA thus asks for 30,000 total.
The logic makes me wonder it a potential approval next time around might only be possible for a sub-population assuming DVAX proceeds w/the 10,000 number.
I don't know Ctic.
I'm still not willing to admit that Daum had ANY valid points, except for the one atop his bony, narrow, pointy skull.
WHERE IS Seal Team 6 when you need them the most????
It's still frustrating (as HELL).
Daum IS the ONLY fingerprints that lead back to GSK in all of this mess; and that "no" vote of his on Heplisav efficacy shows (glaringly) that his view and approach towards Heplisav were less rational than he tried to make it appear (based less on logic and genuine concern for pure safety, and perhaps more of "something else". ) Mercenary reasons perhaps?
The "safety concerns" were thin enough; but a "no" on efficacy in the face of ALL OF THAT TRIAL DATA THAT CLEARLY DEMONSTRATES OTHERWISE.
I'm right there with ya' on frustrations man.
I don't think that more trials, tirals, TRIALS are really the way to go. Clearly, it's the way for GSK to go (in their very English view of Heplisav). More trials are the way to STOP for Heplisav.
Trials ain't gettin' it done obviously, it's "time to change the batter" (as Joe Walsh said)
Earle Grey ain't here for that though, he's here to make sure that Heplisav goes right back down the long-delay-road of 6500 miles (or test subjects, whichever comes first). But first, he needs to have a nice long nap of 3 months or more.
I'm tired of watching other stocks fly; like ONXX for example, while this one habitually blows up in crumbs on the proverbial "launching pad".
After so many explosions and implosions, it's getting harder and harder and still harder to glue the crumbs back together into something of a product and company, never mind EVEN finding the crumbs to glue together.
Is there ANY hope to this disaster? Because the longer we go without ANYTHING BUT bad news, the dimmer that hope seems to grow.
I really curse Dino in all of this (until the end of time); and all of his miserable progeny too....