Its speculation based on the facts that we are GSKs competition, they were actively involved in sabotaging the AdCom and now a fairly high up exec from GSK is our CEO. Im not sure what other conclusions can be drawn, coincidence? probably not, so buy out = yes. When = ?
Great advice. All small-cap biotech down, but we are up just before news from FDA and possibly European approval. Best advice ever. Get your money out while you still can ahead of these potentially positive catalysts. Sarcasm?
They said on the monday of the CRL that the meetig would occur within 6 weeks, which will be over monday April 8th, so hopefully we will get some news this week or next
The history is a bit confusing.
Initially DVAX sought approval for a limited population (older individuals and those with diabetes; groups the current vaccines are not as efficacious with), but the FDA came back and said, seek approval for all people 18-70. Then the AdCom said the study wasnt representative of all people from a racial perspective, which was a bit contentious because it was a large study and there may have been incentive for a particular member to sabotage approval.
Sometimes the FDA says No after an AdCom says Yes, but rarely does the FDA say Yes after the AdCom says No. It leaves them too vulnerable for criticism. So during the actual FDA hearing, the FDA said No, but then said we will rereview your application for the group you initially sought approval for within the next 6 weeks. The hearing was 4 weeks ago yesterday, so there should be news out of the FDA in the next couple of weeks.
In addition, I personally think it will be positive. I think Heplisav should have been approved and would have been approved had it not been for one specific AdCom panelist. I think the FDA feels bad because they were put in a precarious position because of the AdCom and because they told DVAX to seek the expanded indication. Hence, I think they will approve Heplisav for the expanded indication because it is the best way to deal with this situation. They can approve it and let them use the post marketed data to reapply for the expanded indication sometime in the future. This will be much less brutal than telling DVAX to go back to the drawing board and pay for another study. Also, DVAX just hired a heavy hitter to help with manufacturing, so read what you will into it, but I think that is overwhelmingly positive.
Finally, Ive heard a lot of chatter that an EU decision is on the horizon.
High institutional investorship, low float, two sleeping catalyst = pop on the way.
... so we should know on the older population soon.
Hi Nurse, I couldnt find a recent story containing the following words in the Haarertz in English : Protalix, PLX or Elelyso. Could you provide some more info, so that I can read the story? Thanks