To try to bring some sense and objectivity tothe recent announcements here are some facts you blind optimists should digest:
Osteoarthritis:
1. the exosomes did not work. They were not effective. Plenty of biological products ARE effective in models of OA (just google it) so it is not the fault of the model.
2. Where is the data from the positive controlin this model? EX1 conducted the study with a commercial business offering testing in this model so surely such data exists? To claim AFTER THE FACT that the model was “too severe” is plain nonsense or just incompetence in selecting the study in this model the first place.
3. The statement that they need a less severemodel to show efficacy smacks of “just keep trying until we find something thatshows the stuff works”.
4. Where is the peer reviewed publicationshowing their “previous in-house non-clinical, in vitroresults”?
5. What an outstandingly valuable finding that “this study validated the international transport of Cevaris and Plexaris product”. Gee, that might be important in the carrier pigeon age. Putting that statement in an announcement?????
6. And finally, releasing the announcement on 1April, while timely given April Fools, was an attempt to put it out with thetrash before Easter.
Wound Healing
1. despite the hocus pocus headline, theexosomes did not work.
2. besides the fluff around the FACT that theexosomes did not work the announcement was basically a repeat of theannouncement earlier in the year about the safety profile. Quite why it thentook another 3 months to figure out that they DID NOT WORK is a mystery. Maybe they had to get the MoU in place first to try to soften this bad news????
3. No data was provided (maybe the ASX couldtake a look at that FACT). For example, how was the study designed: how many subjects got what and what data led to the conclusion of NON EFFICACY.
4. The statement “Due to the small numbersinvolved in the study there are no significant efficacy signals” is mixing messages. If the stuff was good enough a positive effect WOULD be seen, even with small numbers. Anyway, how does the market know that given NO DATA was provided.
5. To state in this ann “The first-in-humanstudy of Plexaris was a prospective randomised double-blind, placebo-controlledstudy aimed at demonstrating the safety of the product
administered to healthy adult volunteers as asingle dose subcutaneously at the site of a skin punch biopsy-induced wound” issimply selective editing after the fact and again tries to hide the LACK OFEFFECT given that the study was stated thus (from 22 Oct 2020 announcement): “PLEXOVALII is a randomised, double blinded, placebo-controlled phase I clinical studydesigned to assess the safety and biological activity of Plexaris OS inwound healing following a skin punch biopsy in healthy volunteer adults”
MoU
1. No coincidence that this got released immediatelyafter the bad news from the clinical trial. Maybe ASX should take a look at who knew what and when.
2. A non-binding MoU? Really? What a sound base for a 15% uplift in the stock on the back of a FAILED clinical trial ( that is sarcasm).
DYOR
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- Ann: Preclinical Data from Osteoarthritis Animal Study
Ann: Preclinical Data from Osteoarthritis Animal Study, page-40
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