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
The action is supposed to make you nervous. The float on this is so small that manipulation is easy especially with the amount of shares trading, but for the same reasons when this things pops, it will fly; i.e., few available shares. What will shorts have to spend to cover? It comes down to whether or not you believe this will be approved and that is something you have to answer for yourself. Ignore the swings this week. They mean nothing.
No one does know, but the premise that started this debate is not on solid ground since the MMs did/are buying. We entered the new year with 91% institutional investment and have seen several fund increase their shares by several million, so we are probably down to a 5% float. In addition, limited approval with post marketing study has always been what we were after. The FDA extended the treatment group due to promising results. In other words, our limited approval will likely be for a larger population than we initially hoped to target. GSK made their efforts at the adcom and it was damaging, but only temporarily. Longs can expect a nice weekend. GLTAL
I got back in today sub 2.80. May not be the bottom, but Im worried about decision coming down and figured that we only have around 48hrs left anyway, so these prices felt like the right time to me. GLTAL
... so my unfounded prediction is that PLX is negotiating a higher buyout price with PFE right now. PFE def has PLX in a bind with the partnering deal and it makes sense they would lowball us, but Israelis are fierce negotiators, so Im guessing we see an offer just north of a billion. Perhaps $1.2 billion from PFE and hopefully soon. I want to move my money over to SRPT. Please feel free to comment on 1) whether negotiations are occurring, 2)with whom, for how much and timeframe, 3) where you intend to move your money. Thanks in advance.
thanks dash and moose. i opened up a link to patentgenius, which didint show dvax or dina's names, but i opened another link and found it. nice work dash