Sorry, but HC blocks me when I click on links to respond to individual posts.
@LearningEachDay, the second paragraph of my post agrees with you... there are many diseases to be tackled and there is room for more than one company.
However, timing is also important especially in the current climate. A problem for many biotechs right now is that recruiting for their trials has been slowed by the virus. The focus is on that illness. So, my personal strategy is to pick the leader in the C-19 race and concentrate investment there for the time being. Profits can be re-invested in a more "diversified" manner down the road. That's my strategy, I could be wrong... BARDA could give ATHX a huge grant tomorrow. Either ATHX or PSTI could get acquired... Perhaps. But as investors we have to play the percentages.
You have to ask yourself why would a big company want to acquire a little company? In general, the big companies want winners. I can't emphasize enough how important it is to have dose established and to have a full phase 3 up and running in C-19. That's where the action is now. The companies that have large multi-center phase 3 trials underway. So, it's not ATHX and PSTI that should concern us. They are both clearly bogged down in dose finding. For learning, we could ask why that is?
If you're going to invest there, it's worth taking a look at the large review paper by Kabat et al who are academic researchers out of Rutgers Stem Cell. No doubt it's been discussed elsewhere on this board, but just in case here's the link:
https://doi.org/10.1002/sctm.19-0202
They discuss dose-response curves and getting those established is a key milestone for phase 2. In a nutshell it means finding a minimal effective dose, establishing that increasing dose leads to increased therapeutic effect in a step-wise fashion, and sometimes finding that your therapy is so powerful it can even "over-modulate" the illness. That's to be expected depending on disease mechanism, but especially true when cell receptors are involved and become saturated as dose escalates. Having those issues worked out gives confidence moving to the next step where you apply your therapy to a large group of sick patients, also called phase 3. It's knowing your therapeutic - and getting the FDA to agree with you. It's the traditional checkpoint where young promising biotechs started getting eyed by the big established players. They want winners, let other investors take the huge risk getting past the phase 2 checkpoint. If you look at Table 1 in the paper, you'll see that ATHX has never worked out a good dose-response curve in clinical trials... no "less effective dose" is given. Mesoblast has done that, as documented in the paper or do your own research. And it's been done by other researchers working with MSC's. No one else is working with MAPC's, also ask yourself why that is? You'll find that Mesoblast has actually come down from a dose tested in Crohn's, an inflammatory bowel disease. ATHX failed in ulcerative colitis (another inflammatory bowel disease), then tested the same failed dose in ARDS, then took a stab at a higher dose, which apparently wasn't high enough... because now they're going higher still in C-19. And not just a little higher. They are recruiting at one medical center in Cleveland... maybe, or maybe they're holding back to see how things develop with Mesoblast. And they're depending on Japan partner Healios to generate some data, which has been slow coming. So a company that depends on others to control its fate. It doesn't strike me as an enticing target for an acquisition/huge BARDA award at this point, but like I said, I could be wrong. Regarding PSTI, they're planning to give 15 IM injections to unconscious ventilated ICU patients who may be hypo-perfusing peripherally and are often anti-coagulated. I don't think that's going to fly in ICU's. Again, I could be wrong...but they are also bogged down in phase 2 dose finding.
@LJohn, I've written about CYDY on the "analysis of the EAP" thread... it appears to be an excellent mAb in the hands of management that has made a few mis-steps and likes to hype. It's on my May 21 watch list of competitors. For C-19, in general it's targeting an earlier phase of the illness than rem-L. Which means rem-L will get its failures / patients who can't tolerate it due to side-effects / adverse interactions, toxicities etc. As with several mAbs in the C-19 race, we are waiting for trial results. I would tend to invest more there than with other cell-based therapies.
There will be successes out there with other therapeutics, from mAbs to anti-virals to inhalants to vaccines and others. These will no doubt help some patients and are worthy of investment consideration. But no one therapeutic is going to have all the answers for all the patients with the complex illness designated C-19. So, I like being positioned as "medicine of last resort" in the ICU. That's just a great niche to dominate. We'll take all the failures of the others, and there will be plenty (see my first post ever on HC). So, I'm more concerned for anything that might position itself downstream from rem-L... that might take rem-L failures. Other than ECMO, a mechanical treatment that buys time, I don't see anything that's a medication. There are the other cell-based therapies that are running trials... but I believe they are well behind and in any event will have IP problems. Only one cell-based therapy will make it, only one "medicine of last resort", and that's remestemcel-L. I"m invested accordingly. But do your own DD. glta
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