Today the calendar says "December 29 2012" exactly one year after I wrote "Reality Check" Part I on December 29 2011, as an introduction to the third edition of my investors webpage on Cytori Therapeutics. A lot of effort on a cause, in which I (still) strongly believe, but which has so far, always emphatically proven me wrong. Obviously, the faint of heart would have conceded a long time ago, but I believe that to be a big mistake, if one is a long term investor (traders have their joy always here, if competent in their profession). Even if I (unfortunately) was right one year ago- see text below or link for the complete article- HERE- I do believe, that for good reasons explained below- Cytori is finally at the crossroads to "greatness"
But first part of the text of the "Reality Check" article from December 29 2011:
But REALITY today is that we are staring in disbelief at a share price south of 2$ for the organization thatholds most of the intellectual property of ADRC technology and also "scientifically" discovered their potency 8-10 years ago. Now- isnt that something!! Yes- it is unbelievable that the folks in San Diego -thus far- have been incapable to monetize on their position in this field and let the "rest of the world" catch up to a large degree and taking advantage (legally- or illegally) of the inept attitudes and lacking "sense of urgency" to develop the platform technology.
The year started pretty well in 2011 with the confirmation of some vital patent applications by the USPTO. But than, instead of the eagerly expected confirmation of events anticipated- sheer silence accompanied by the issues of bi-weekly low priced shares on the market.Horror to the tenth degree- even the announcement of CE mark approval for Celution One late in 2011 (guided to receive in Q2 2011) was extremely subdued- no mention that the machine was substancially equivalent to Celution 800 and received the same therapeutic claims. I can assure you- it did. Some folks have gone nuts over there in SD apparently or cant think clear anylonger. Same thing with the FDA- frenzy legal activity untill August after two no-no´s on filed 510k´s, but NO activity since that date. I can tell you- plain weird.Time will tell- I wont proclaim 2012 as Cytori year- NO WAY- but all I can do is buy shares and hope that incompetent managers find their nut according to the blind squirrel theory.I hope they will and if that happens to be a sizable nut- I might even be willing to forget all the agony of the past ten years, but than again- we have been through that every year.
So why should things be different this year- in Year 13 (i.e. 2013) after "inception" so to speak?
Two major reasons I can provide you:
First- for Companies dealing with "disruptive" technology- regulatory hurdles are hard to jump and can "kill" an organization not preparing for "Plan B or C" in case the "expected" is not realized, due to lets say maybe "corrupt" or maybe "simply biased" regulatory authorities. The - not announced- but still extremely important Japanese approval for "Class I" device for Celution was a great step in the right direction, but the situation with the FDA and MHLA- the competent authority in the UK- together with its Notified Body, BSI, were still a great concern, despite the important approvals (added claims on Celution) received some time in the summer. Cytori only revealed those events at the Conference Call (???)
Why was -after almost two years of investigation- the cardiac application- Chronic Ischemia, based on PRECISE clinical data not approved for marketing? Thereto Cytori issuing themselves, totally confusing statements on the approval for "Intravase", which a savvy investor with adequate knowledge of the Company and physiology, like myself, could not even understand?
Those concerns are- for myself- erased by the excellent find of Yahoo user "Joecav", who discovered the Cytori response to a "Call for Evidence" from the UK House of Lords, asking for an assessment of the UK system of regulation for innovative technology. Those guys, that is- Cytori and BSI- seem to like (love?) each other, boding well for future regulatory developments, which to me, were a major concern. The issue with the FDA isnt resolved with this, but my desire- a deal, which lets Cytori sell Celutions for translational medicine to well respected university clinics only,as an example, isnt too unrealistic also.
Second and foremost- after deliberating with myself over X-mas (and several days more) and asking myself, why is a Company with good people working for it, having created such a basket full of patents, meaning important IP protection for the market they participate in; thereto a substantial amount of marketing approvals for therapeutic applications, which are however not pursued by a large internal sales organization; together with a developed (and almost mature) device, which is likely unique in performance relative to its peers and thereto IP protected, is in the dire state it is in at the beginning of 2013?
The answer I have come up with, is relatively simple and the following- Cytori is a good Company- they have done a good job as an organization, but its management have made key mistakes in the past. I do not want to reiterate all of those mistakes here, since they are adequately documented on this site, but the cup has "runneth over" and changes SHOULD be made, which I believe Lloyd Dean (picture) WILL make.
Reason being, if I see those mistakes from the outside, it is hard to imagine, that a high calibre manager like Lloyd Dean, who has been on the inside for over two years- does NOT see them and will act accordingly. My prime reason for strongly believing that 2013 will be Cytori´s year, has a lot to do of expecting changes in the organization to the benefit of shareholders and NOT management for a change.
So- there you have it-
Obviously - I run high risk of having to eat my words with an announcement next week of a super partner deal and everybody happy. I do not think that would be kosher- too many failures and broken promises, the most talented successor- please stand up!!
If I do have to swallow my words- thats fine too- I will take a long break from Cytori than, but will remain to have the same number of shares..... for obvious reasons.
However- just to conclude- 2013 -all in my humble opinion- will be Cytori year.
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