No, that is not the question being asked here. The question relates to whether Worlds appropriately identified the priority date of its invention in the chain of its patent filings. It has nothing to do with whether Activision infringed and yes a Markman hearing will be needed. It would however undoubtedly be an enormous setback to Activision in that they have pinned so much to this MSJ. What that makes any serious observer believe is that Activision may not have too many more bullets in the gun. If they try a later MSJ on another "case dispositive" finding, the judge will rightly ask why they did not bring such an important issue up in their earlier MSJ. We continue to believe that it is well within Judge Caper's purview to make a correction to the face of the patents to affect this specific case. Activision's attorneys told her essentially that she did not have that authority and I'm not sure that such an approach was prudent. Whether she utilizes that authority is another matter. Our original thought was that she would deny the motion and allow Activision to bring it up with a jury or on appeal. We still think that is most likely but of course there is no surety in that.
He makes a bunch of erroneous conclusions in our opinion since the ADCOM recommendations were not for overly restrictive labeling. Look at Adam Feuerstein's comments on that subject - love him or hate him there is no disputing that he is the most deeply schooled and entrenched author in biotech today. The mandating of the additional study is quite frankly significant enough. The most important thing is the ability to prescribe. If the FDA says that efficacy can't be confirmed beyond 2 weeks that is not restricting prescription beyond two weeks, big difference. There is no other treatment for NOH and none on the horizon either so cutting people off at two weeks when the drug has been selling for a decade and more in Japan is ludicrous. I don't anticipate CHTP launching the drug on its own but at the same time what kind of bargaining position would they be in if they took no steps to do so? Additionally, the idea of a prospective buyer using the further on study to leverage a better price is a pretty obvious thought. Buyers are always going to come up with negotiating points to leverage. The problem is that that can cut both ways. If they agree to a lower price (my guess is no less than $800M discounted on an outright buyout) we may see $9-10 rather than $12. The stock sits at half that today. They can also build in a post 401 study payment (if/when effectiveness is concerned) that provides them with more money than they would have made if they prove longer-term effectiveness. One other thing. The options activity does not support EPE's price expectations in any way. The only reason this stock has been kept down is the incessant FUD that has been spread. This is just another example. At least EPE sees an approval coming tomorrow and to that we can agree. As always do your own due diligence.
I wrote on my blog last week that this stock was an excellent growth candidate for 2014 and that my group would be riding a substantial amount of shares into the FDA decision on its Versafilm Migraine strip. While of course we and everyone else would have liked to have an approval (and we pointed out then that nothing is ever a 100% certainty with the FDA) today, this CRL as reported by the company, is actually quite encouraging. While we don't have a handle on the specific third party manufacturing issues cited in the press release, we note that the company filed an amendment to the application which presumably addresses at least some of these issues. The fact that they are saying that they feel they may be able to re-file in a month's time is quite encouraging. As they pointed out this is not about bio-equivalence or safety, which is something that may have dissuaded a potential partner. This CRL is likely only to embolden anyone that they are in current discussions with. Disclaimer: We are Long IGXT. We will use the occasion of any strong weakness to add to our position. Please do your own due diligence and do not rely on us or any other source without consulting with a trusted financial adviser.
100% TRUE. This is incredibly validating for Vringo but I think there is still concern on the part of investors about the workaround so until that issue is resolved this is unlikely to have a major breakout. If VRNG winds up getting $150-200M that will be great and provide a decent lift but nothing like $700M+ will. I can see this going to $3.5-$3.75 on this news but I don't think it will hold. Only news of w/a still infringing and subsequent final order on damages given that will get this where everyone hopes.