Hey buddy. I knew I liked u for a reason haha. Agreed when it’s all said and done I would one day like to pick your brain on your other life.
So it’s all ongoing, so people have been getting dosed and completing the trial all along. I’m trying not to summon our friend on here who loves saying that ‘the company is blinded!’ —- so I’ll tread lightly here. One may argue that in a world of black and white, a company would have no idea what on earth is going on with their massively expensive trial until the fat lady sings and it’s all done with. But it just doesn’t happen like that, generally. So a company is going to employ someone to be a sight director and oversee the clinical sites, it may or may not be the same person for multiple sites. Essentially that person or people is making sure that all is progressing. It’s also their job to make sure that their data collection makes sense... ie they aren’t getting really weird data. Interim data analysis is the name of the game. Whoever is running the show with the trial, they are going to keep an eye on what’s coming in, data wise, and make sure that they don’t have a problem. They are also going to keep an eye on what’s going on medically, ie... what is the frequency of adverse events any serious bad outcomes, anything negative enough to consider halting it. So to illustrate... we got the enrollment criteria stuff adjusted for lipid drug. In order to make a case for that to the FDA, you need to show the FDA what’s going on, why you are failing to secure patients, and you need to make darn sure that you are making that calculated risk in the right setting. They would have to decide if they feel that individuals with lower LDLs for example will still be able to benefit enough points wise in improvement still, to where you will still get statistically sig results. You generally won’t know that answer unless you have massive quantities of phase I data to rely on, or more likely, you have done an interim analysis of available data and are seeing enough of what you need to see in the population you are about to adjust things to. So imho, when they got the FDA nod to alter enrollment criteria, somebody probably saw what they needed to see, to de-risk the proposed new population. Otherwise, they probably would have let the trial trickle along with enrollment. Much Easier to enroll for a long time and answer questions on a delay, very hard to design a whole new trial to do what you meant to do the first time, and to tackle the enrollment question all over again.
So ‘someone’ has had a lot of data for a long time now, as people have been finishing for awhile. Some trials are really tiny and easy to enroll, so it still happens where some trials do it all at once and get stuff back quick and see what they got. Large multi center trials are a pain to organize and execute. All this jazz about ‘we need to transfer the images’ —- well... yeah. You need to physically own all that data, and be able to prove your trial claims if someone questions you, so they need to physically possess it all. But in reality, someone reads those studies, and there is a tech who does the leg work of getting the patient where they need to be. Every time they get images, someone is responsible to make sure that the images/data, technique, is acceptable. Kinda like getting an MRI done... they have someone there or remotely who looks at your films to make sure they were done correctly, and will be able to be interpreted. It would be a massive failure if you just put everyone through a DXA, and then send the data, and realize that your machine screwed up/you obtained the images incorrectly or differently than another site/or that you are somehow getting totally different findings on those from a single site, like a huge outlier. These studies cost a fortune, and whatever they are calling our company... you can bet that someone from ligand is helping them to make sure they aren’t screwing this up. And these are all legal things and totally fine... don’t even get me started about the way that some trials are run. So yeah, in a perfect world, nobody knows nothin forever, but in reality, not the case. Let alone, everyone is on the payroll in most trials, site directors and quality control guys are answering to someone... someone is asking ‘what is the progress with x and y and z...’ it’s not a ‘what did this weeks numbers look like convo’... but every now and then it gets close to that. It’s also why our company was able to give guidance that they anticipated 2-4 weeks to clean up the data. If nobody had seen anything, how would they know how much work is going to be involved to integrate and clean up data from so many independently running sites. I’m not too worried that we haven’t heard anything. I’m getting the ‘master plan’ vibe lately, with the ligand conference, the bread crumbs we got not too long ago on the early trials... they can’t ethically delay results, once in hand, but you can hold out your hand really slowly when you have a hold on what your overall progress has been, and you just need to put a few more values into the charts as people finish up their dosing and trickle in. The closer these results are released to the upcoming lipid results, the richer we all might be. It’s a welcome prospect to think that we could announce news very late this year, and have a 3 month gap for lipid data... as ya know, big gains are easily lost, when future catalysts are far off. I’m liking where this is headed, but it’s all still just a shot in the dark. So the entire company doesn’t hadn’t gotten the ‘things went good’ memo yet... but somebody has been sitting on a pile of something for awhile now, and is actively working to shade their argument with data as we speak. Charts and graphs can make anything look like anything, in the right hands, that’s the game... and of course, meeting that primary endpoint. Loved their explanation for why they picked lean muscle mass btw... because it showed great data on that the first time, and seemed like the surest bet. They may find a few gems in this trough of info that may change future directions, but for now, they picked the easiest thing that was likely to be ok, to justify all the other data they wanted to get.
Hope all that helps!
Enjoy the weekend all, cheers
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