DVAX pricing components
> Is DVAX a buyhere?
This is a good question. Basically it boils down to
a) the amount of money the HBV vaccine will need for a third approval attempt
b) the value of the oncology / immunology programs
For a) I am a bit sceptic about the FDA "not asking for another study". Back in the past the CHMP/EMA in europe had asked for a much larger safety study than what DVAX actually did for this BLA with ~ 5000 (and if they had done a much larger one, then is would have been much less guesswork for the FDA, which might be the reason for the CRL - too few data and for this reason a very careful stance asking about "everything").
So if they are looking for a partner, then it could mean that this partner (if it is a big pharma) might be inclined to do another 10-20.000 patients study.
For b) Actually this is what too few people have been taking notice of. PD-L1 is a much too crowded field. DVAX is a kind of immunology company here with it's adjuvants in oncology (please recall: the only new component in the HBV-vaccine is the TLR9 agonist as adjuvant, not the HBsAg). Much simplified, the idea is to make "cold" cancer "hot", visible for the immune systeme.
Gilead's Bischofsberger once said, they are not interested at all in any "me-too" PD-L1, but rather compounds that work where PD-L1 does not.
So, is it a buy? I am not sure, since a) introduces a bit too much uncertainty. On the pro side, the much inflated price has dramatically decreased. On the con side, I am not really sure what their cash burn will be in the near future + before making a decision to sell (ugh) or buy more, I would like to see some results about their SD101/TLR9-agonist in oncology. As well, the type of partner they will find might influence your decision (I'd be somewhat more sceptical if it was some financial instead of a pharma partner).
My 2 cents.
dM
