... so hopefully will get and answer on it, but would like to hear any of your THOUGHTFUL opinions. Thanks.
I was wondering about your thoughts on the potential approval of DVAX's Hep B vaccine candidate, Heplisav. Specifically, do you think it's possible the FDA will approve the vaccine after a negative Adcom recommendation for safety? Has this scenario ever happened?
To recap, the panel voted "Yes" 13-1 on efficacy. The one "no" vote on efficacy was from the same panelist who made a fuss over the racial makeup of DVAX's trial, which seemed to be the leading argument for the "No" vote on safety. The argument was that the trial didn't represent the racial distribution of the USA. First off, I agree that a trial should be representative of the potential patients, but this can mean a lot of things (i.e., disease burden, obesity, etc), not necessarily US population. Secondly, why make this point with some small biotech where the argument will go unnoticed? Seems like it would have more impact to breach the subject with a big Pharma trial, which undoubtedly also have potentially negative biases.
The unsubstantiated answer to these questions is that the panelist is a consultant for Heplisav's big Pharma competition. Heplisav is disruptive to the Hep B industry if only for its dosing regimen. Compliance is much more likely over two doses in a month than three over six months. This may seem small, but from the public health point of view its huge. Thus, it would make sense that someone with financial interests in maintaining the status quo would be looking for an excuse to crush DVAX.
In addition, it seemed odd that this was the only person who also didn't think Heplisav was efficacious. An axe to grind? Perhaps, but to make matters more complicated a member of the FDA was present at the panel and when this panelist made a fuss over the lack of adherence to the US racial distribution, the FDA representative said the trial was more than sufficient and the drug was at least as safe as what has already been approved.
This leads me to feel there could be a chance of approval, albeit with post-market study and some restrictions, on February 24th. Is it possible or is the fact the Adcom said "no" to safety too big of a hurdle?
So, tell us all, Ctic, what does your bald, creepy, little, master meinfeuherstein give you for an answer to your big question?
I'll tell you ahead of time that he's bettting against Heplisav and has been. He obviously backs GSK or Merck or someone other than Dynavax.
His answer won't be anything positive to say for Heplisav, but I don't think that he can be right all of the time.....
Can someone please tell me what these so-called safety concerns are? Because I listened to the meeting and read the transcript, and I cannot find anything specific. Certainly nothing concrete that would preclude the FDA from an approval.
What I did find from the panel meeting was (I am paraphrasing):
#1 - ONE Panel member thought the racial make-up of the Phase III was not representative of the human race, and
#2 - comments that the use of the adjuvant was novel and needed further testing to make some panel members comfortable. Saying the study size was "too flimsy" but offering ZERO indication as to what size would not be too flimsy.
Arguably, #1 may be true that the sample size was not strictly representative of minorities - but so what? And #2 is simply an open-ended opinion. While an additional study database of 3000-5000 more would presumably satisfy one member, no explanation was given as to why the study size would need to be larger for *this* particular adjuvant vaccine versus other vaccines that have been approved with identical size.
Anyway, the concerns expressed were for the entire general population, not the original study pool.
So does Heplisav get approved - yes. No doubt about it. Is there a possibility of limited indication - maybe.
Does DVAX with an approved Heplisave warrent $3 pps. Hell no. Deal of the Year right now at $3.
No need to further explain safety concerns, you nailed it. Hence my question about if the FDA ever votes Yes after an No from Adcom because it sure feels like one person (who may or may not have financial interests to do so) may have derailed the approval. Anyway, it sounds like there is precedent, though shaky.