smh - just to follow up on the idea that the cautions and concerns you find in HDII's background are beyond commonplace, let's take a similar examination of the latest prospectus from Biotransplant. My obvious point is that if you express concern for HDII's status, equal if not increased concern should be directed towards BTRN (all statements taken verbatim from BTRN's prospectus- see link below)
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- We have not successfully developed any products to date and if we do not sucessfully commercialize any products we will not be profitable. We have not yet completed the development of, conducted significant clinical trials with respect to, or marketed any of our potential products. If we are not successful in developing and commercializing any products then we will never become profitable.
-Neither we, nor any other company, has successfully developed and sold the types of products we plan to develop using our technologies. The products that we are developing will require additional research and development, extensive preclinical studies and clinical trials and regulatory approval prior to any commercial sales. In particular, we may need to successfully develop multiple novel technologies in order to complete development of our AlloMune and XenoMune Systems. Moreover, these products may not be effective in solving any of our targeted disorders or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may prevent or limit commercial use.
- Our ImmunoCognance technology is complex and novel. MEDI-507 has been tested in relatively few patients and we may not be able to demonstrate the clinical benefits of this product. Furthermore, our AlloMune and XenoMune Systems are based upon technologies which, to our knowledge, have never been implanted in humans, including by us. Our technological approaches may not enable us to successfully develop and commercialize any products. Even if our technological approaches are successful, we will need to undertake substantial additional work to translate our discoveries into products.
-Our XenoMune System is based upon the transplantation of organs from miniature swine into humans. We have little precedent for this procedure and previous attempts by others in the xenotransplantation, or inter-species transplantation, field have not been successful. No xenotransplantation approaches have been approved by the United States Food and Drug Administration, or FDA, for humans.
- We have limited experience in conducting clinical trials.
-There is limited regulatory precedent for the approval of products based upon the technologies that we are employing to develop products. For example, the FDA has not yet established definitive and comprehensive regulatory guidelines for xenotransplantation. Because the AlloMune and XenoMune Systems are based on new technologies and new therapeutic approaches that have not been extensively tested in humans, the regulatory requirements governing these types of products may be more rigorous than for conventional products. As a result, we may experience a longer regulatory process in connection with any products that we develop based on these new technologies or new therapeutic approaches. For example, the FDA has not yet established final or comprehensive guidelines for xenotransplantation.
and the list goes on...
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Now it would be fair to say that concerns about HDII's competition - *for a product that is already on the market* - pales in comparison to the foundational, fundamental issues on BTRN's plate. You may respond that the 'boilerplate' issues presented in the BTRN filing is commonplace for many biotechnology issues. You would be correct although their universality should not diminish their importance. Moreover, if BTRN's warnings are commonplace and a given in BT/medical device company investing, then the fact BTRN currently doesn't even have any marketable products...while HDII has a product already out in the marketplace suggests that concerns about HDII's competition dwarf in comparison to BTRN's potential hurdles.
In light of these facts regarding BTRN - which I can assume apply to a similar degree to SEPR, MLNM, and VTRX - I would assume you made equally probing questions on the relevant threads based on what must have been even deeper concerns than you had for HDII (could you direct me to those posts...?). Again, the fact that HDII has at least one product on the market currently, and two either approaching or undergoing FDA review, sets HDII apart from the other companies mentioned.
So smh, a legitimate question - did you pose such excellent and rigorous questions to the proprietors of the BTRN, VTRX, etc. threads?
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Reagrding HDII, the company lists multiple advantages of its proprietary CV monitoring system and I'll review this in a subsequent post. One example, given in your post ('To the best of our knowledge, no products which measure both large and small artery elasticity have yet obtained either CE Mark or FDA clearances to market, and no other products being developed or being marketed appear capable of providing both large artery and small artery elasticity values.') indicates they do indeed have a unique and proprietary product. Why would they place that straightforward statement in an SEC filing if the essence of the technology could be, in your words, 'fairly readily and independently developed'. If that were the case, with the size of the current and upcoming CV market, and with the substantial financial backing of much larger companies, HDII's approach would have been easily replicated and/or independently developed long ago. And it is clear the CV monitoring technologies already extant do not match the sensitivity and scope of HDII's.
I too have made several X on HDII (and multiple X on ARIA) and the rise in these stocks, as in yours, were not, I can assure you, based on a line by line evaluation of each company's 10K 'risk factor' section. If this were the case, there is good reason to believe HDII would come out ahead.
More later...
The link -
freeedgar.com |
