Holden:
J,
I wrote this on 3/13. Partially explains why SP is not higher.
"Danny, are you trying to tell us that markets are efficient? I have been an analyst/portfolio manager (now semi retired and doing other stuff) for 25+ years. I have made a living and then some off market inefficiency. I can tell you from the genius analyst's answers to recent and past questions to ARWR that they haven't a clue. And why should they? The JNJ deal took any possibility of a large underwritten deal off the table for the next five+ years. Do you think analysts get paid for being right? From picking stock winners and losers? No No. They get paid by bringing in banking deals. So why take the time to get really smart on a small development stage company when there is no banking business in it? No paycheck in it?
Getting back to market inefficiency...I wrote a bunch of put options on ARWR and took in a bunch of premium exactly because the market assigned an incorrect price on the underlying stock and a totally distorted price on the related options. Those puts expire Friday. I am going to do same on Friday. It's called adding Alpha. I can tell you that I cannot add one basis point of Alpha to the FANGS. Mr. market has appropriately sorted out their market caps/share prices. But ARWR is largely undiscovered and thus does not have an appropriate valuation assigned to it by Mr. Market. On a risk-adjusted basis this is the best opportunity I have seen in my career. The sell-side analysts don't give a hoot about it. It's too small for a large swath of the major mutual funds and pensions to care because owning 5% of a $2Bn market cap doesn't move the dial at a $30Bn fund. So while the "Market" trades ARWR shares at $19.50 or so, a HUGE part of the market is completely sidelined for structural reasons. Gotta go figure out what is the next put writing plan I need to execute."
J, In short, there is no one event that will all of a sudden drive the SP remarkably higher. I can say with certitude what SHOULD IMO drive the SP higher. FDA approval of what I have termed, "The Gottleib Construct. (GC)" GC is is the seamless transition from p2 to p3, in between which it is determined that both primary and secondary endpoints have been met. Normally when this happened a company must apply for early termination of a trial such that it can unblind all subjects and give drug to placebo patients. Then the company may file and IND for commercial compassionate use labeling in a p3 trial that is a called a post-marketing trial. In other words, this aggressive but possible process has included two filings. What I believe ARWR has filed to do is ask that the FDA allow ARWR to simply append their p2/3 filing with new data from the p2 part of the trial that proves out both primary and secondary endpoints have been achieved. Further, they have asked that the FDA grant commercial labeling without a p3 application and NDA. So rather than a shutdown filing and a p3 IND/NDA, ARWR is looking for what it has termed a seamless transition from p2 to pivotal p2 to p3 with no additional filing. Simply more robust data, all details of which would have been spelled out in the filing that ARWR announced on 3/18/19 after a huge interactive effort between the company and the FDA. I believe that is why BG and CA both emphasized that we will NOT likely see data from this study in 2019. Again BG emphasized that there would be a lot of subjects in the study bc for the FDA to grant the above they would have to have more than the standard data set they would accept for a normal orphan p2 study.
This would be a monumental grant if in fact the FDA allows this study to take place as I have suggested. It will affect not just ARO-AAT but also ANG3 APOC3 which appear to have been designed with a similar path in mind. I have further postulated that AMGN's recent changes to its AMG-890 LPa study was made to follow the ARO-AAT path - patients reduced for the p1 portion of the study. We'll see what the FDA grants but if they grant the above, this will shave years and many millions of development/commercialization dollars. The compressed time is most relevant and is 100% in line with Gottleib's vision for the FDA which is to get many more drugs on the market to create more competition to drive down drug prices. This is also Trump's vision and a big part of what I believe will be his proposed healthcare overhaul. I think we will know inside of 60 days. It is for this reason I believe the approval of this IND SHOULD power up the SP. First time in the history of the world and surely the rest of world will follow the FDA's lead.
Cheers
https://finance.yahoo.com/quote/ARWR/community?p=ARWR