Voclosporin will likely be approved well before the P3 trial runs it course. Here's how it's going to work. First, there's a legal and regulatory path for this approval . While I quote the relevant passage below, here's the link to the FDA Regulations , as well as a list of drugs t hat received accelerated approval. Sec. 314.510 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity. FDA may grant marketing approval for a new drug product on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoin t that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity. Approval under this section will be subject to the requirement that ...
I would be surprised if the company is NOT acquired before the end of phase 3. With compelling phase 2 data and a good possibility of replacing Restasis as the best drug for dry eye syndrome, why would a BP wait to pay more for AUPH when it could pay much less before the LN indication is approved? That makes little sense. In addition, you can bet that Mr. Duggan will be advocating for a fast return on his huge investment and advising Glickman just exactly how to get it done. My bet is we see a buyout within 12-18 months if not sooner. Every month that goes by raises the price on the company. I am hoping that the mms take this down to the 5's this week at which point I am a buyer again.
ReplyDeleteYep, I agree. Amazing downward pressure, and no doubt many retailers will cave and accept a loss. This stock, and these biotech games, are not for the faint of heart. It's hard to forget the facts at times like these, and therefore good to recall them....Phase 2b results were superb, and lead to estimates of the company being worth 3+ billion. Phase 3 is just getting underway, so there's no "bad news" to explain the downward price movement - the value of this company has not changed one bit, and it actually increases over time as we get closer to the BO and results from P3. Time to turn of the computer, I believe.
DeleteIn the absence of news the mms are free to play the sp as much as they want. Panicky retailers inevitably sell at the worst time. Institutional investors are buying the cheap shares as they become available and the percentage of institutional investment continues to rise. At some point an equilibrium will be reached and than the sp may remain at that level for quite awhile. Many retailers already worn down will eventually have had enough and sell at that level. When things look hopeless the few remaining retailers and the patient institutional investors will watch as the sp alowly starts to ascend culminating in a buyout. This process will occur within 2 years imo. Will be watching to see how low they can take it before it reaches equilibrium. My guess is low 5s or high 4s. Might put in a bid at that level.
Delete"My guess is low 5s or high 4s. " If that happens, what an incredible gift!
Delete“The best thing that happens to us is when a great company gets into temporary trouble... We want to buy them when they're on the operating table.”
-Buffet 1999.
“And if they insist on trying to time their participation in equities, they should try to be fearful when others are greedy and greedy only when others are fearful.” -Buffet 2004
cheers