Hey buddy,
Re-read it today. Here's a couple thoughts. All in all, a very good call, imho. A few things to consider. In order of when they appear in the call.
"we've been notified that our abstract received the 2018 most outstanding clinical abstract award by the ASBMR conference organizers." So... the ASBMR stands for "American Society for Bone and Mineral Research" and their blurb is 'cutting edge bone research.' We had a clinical trial designed initially to look at muscle mass change. I'm not trying to leap to conclusions, but this in my mind suggests that there may actually be something to what they started hinting at earlier in the year... bone changes and fracture healing changes. So if you are more active in physical therapy you are probably gonna have better fracture healing, (seems obvious). So maybe it's just as simple as possibly improved fracture healing being related to better functional status and improved therapy participation (if better bone healing does exist, it's being hinted at unicorn still). But again, if this turns out to exist (and honestly it's what I am currently most excited about in the 5211 realm), it could actually be drug related. So, you may or may not know this, but anabolics can change people's physical appearance, one example being, giving them a more prominent jawline, kind of a cave man type of appearance in some ways. I forget the exact biochem pathway and maybe I'm blurring the lines with HGH (human growth hormone compounds), but possibly our drug could have a similar bone amplifying type of property as well. It's a shot in the dark. I could go on and on about that one, but I'll let people run with it from there in their minds. I will add that it would be slightly unusual for the most outstanding clinical abstract at the yearly bone conference, to have nothing to do with bones ;) that's the real key here, the big elephant in the room in that realm. Sure hip fractures are broken bones, but there has to be a sizeable link here to earn them this much notariety in this type of national forum. So honestly I think we may get a surprise or two at the Sept 30 conference, or at least it's a little more than possible in my mind. Lots and lots of abstracts get submitted, this is a big deal, this nomination, much bigger than just being a plenary presentation, they are saying that we Are the presentation to see. Why that's the case, seems like more than just what we currently know about the topline stuff. I'll leave it at that.
Next one- related to what I discussed above
"It is our belief that VK5211 may represent an important treatment option for these patients by STIMULATING THE FORMATION OF BONE AND MUSCLE thereby improving musculoskeletal health and facilitating recovery from the injury. Related directly to what I discussed above. I was all-in long ago thinking that just giving anabolic like drugs could turbo charge physical therapy recovery. Again, this is a big deal if it pans out. Like easy pathway to approval (if it exists). If you could show that SARMS have anabolic like bone growth properties, and use them in a sick bone fracture population that ends up immobile due to hip fracture, this could be the key to the FDA puzzle that has left others short-handed in the past. No joke. It may be a direction they choose to travel in with subsequent trial as well. Also may be why they are looking at partnering with the types of pharma companies they have discussed.
Next one- Re: 2809 "the trial Data Safety Monitoring Board continues to receive regular updates from the study, and has continued to allow the trial to proceed as planned." Ok... this is an education piece to reference stuff I have talked about before, and to shut up all the nay-sayers who claim that a company has 'no idea' what's going on in their trials, until they get the data. Not tooting my own horn here, just saying, this is obvious stuff to me, but shorts love to claim that trial results are like magically unknown until the trial is over. They have to submit ongoing safety data (ie. ALT LEVELS) as the trial goes on, and the trial is allowed to proceed. This is what I've been talking about. The fact that they reached end of enrollment and were allowed to proceed, makes some random huge ALT elevation problem really a lot less unlikely. This is a little bit of powder to back up that kind of stuff. Doesn't exclude any problems, but makes big problems less likely, the longer Any trial is allowed to proceed, not just specific to us. Reassures me.
Next one- They will begin dosing in glycogen storage disease this quarter (using 2809). The fact that they are moving full steam ahead with 2809 molecule in other indications, at this juncture, also seems to suggest to me that it is becoming less likely that major side effects are coming. Just speculation. Also excited to hear that the glycogen storage disease next trial of 2809 is going to have 28 day lipid data readouts. Starting it later this quarter and getting data readouts in that time frame, means we might get promising follow-up data from 2809 not too long after the phase 2 LDL/NASH readouts... no waiting a year or anything for 2809 to re-emerge to the scene. They are stacking the deck with a lot of data readouts a few months apart, really smart stuff imho.
Next one- (back to 5211)
"When you look at the muscle that's involved in stress urinary incontinence, VK5211 has shown very robust efficacy at an extremely low dose." So I was thinking about this stuff over the weekend after giving the CC a quick read, and had a revelation that I should have realized before. I was wondering how they would know this... and well... duh moment. So they are using DXA scans and other imaging to evaluate the muscles and bones AROUND THE HIP for 5211. What's right next to your hips (right between them actually) --- your pelvic floor. I don't know the protocols they used to guide and direct their imaging, but there is a chance they may already have more pelvic floor muscle data (or at least a rough roadmap of what's going on), based upon the areas they are concentrating on with the hips. To make it vague and illustrate my point - if I order an xray to look at someone's lungs for a cough, I'm also gonna see their heart, and their shoulders, and some of their intestines occasionally, etc. Also a likely reason why they are waiting on GTXI's data. Why even go there, pushing the pelvic floor muscle theory, until GTXI proves that there is something to the theory that strengthening pelvic floor muscle will fix urinary stress incontinence. Wait until they prove the linkage, then delve deeper after the argument is strengthened... then it would make perfect sense to approach that angle, because likely they have some degree of access in a broad sense, to what their drug does to those muscles. We see muscles on CT scan all the time, and how big they are, this isn't rocket science and won't need incredibly advanced testing to look at, compared to what we are already using to look at the hip bone/muscle area. Also, it would be nice if GTXI would rocket on the news, it would really help Viking to figure out just how big of an ace card they are sitting on, and to what extent they need to partner. Like whether or not to license out the compound for all future indications, or just for an isolated one like the hip, etc. That's getting a little advanced, so I'm gonna stop there, but you get the picture.
To all fellow longs, hope all is well. I check the other boards and see all the typical jitters on there, people hitting the panic button because we are in that awkward lull period before the fireworks. I'm still holding strong over here and am truly excited for the possibilities of what's to come, with these upcoming catalysts. Hope all is well gents, happy trading and BOL. Waffles
