Your observation is right on, piracicaba. It is becoming clear that Cytori has a tighter relationship with the FDA than any other stem cell company. Cytori went DIRECTLY to a pivotal trial on scleroderma based on a very small independent study out of France, which to me was a big accomplishment. Now this news further demonstrates the Dept of Human Health Service's interest, enthusiasm and commitment to the technology. And they should be enthusiastic about Cytori because the FDA has stood by and done nothing as hundreds of stem cell clinics, with lesser technologies that have not been vetted by the FDA, operate in clear violation of their own rules. The HHS and FDA need this Cytori to move forward quickly so when they do clamp down on these clinics, they can offer patients and doctors an FDA approved device for stem cell treatments.
With the data that Cytori has on Scleroderma and with the FDA go ahead for a Pivotal trial, if what Mr Mills is saying holds true, there is every reason for CIRM to fund this trial. It would likely be their first major success and first FDA approved stem cell treatment.
Even though I think there are many good things going on, as I listed in a prior post, you are unlikely to see any articles from me until the balance sheet is shored up. Its a shame too because there are good things going on with Okyanos and Lorem that could lead to a revenue ramp and I do have interesting ideas for an article. Maybe you want to give it a shot?
First of all let me agree with Roth about how pathetic it is to celebrate $.50.
Having said that here are some important points:
1) Pivotal: Going directly to a FDA Pivotal is a big deal since the company never did any previous trial on its own. Is this a more flexible FDA we are dealing with? Approval means a reimbursed therapy in the U.S. also a big deal.
2) ALL Patients Will Have Option to get Treated: This is critical, IMHO. One of the problems in previous trials has been recruiting patients. Some may be reluctant to get a lipo when they may not even get the real therapy. By offering the placebo treated patients the real cell therapy treatment AFTER the trial is completed should help recruitment happen much faster.
3) The independent French study that preceded this was open label, yet it showed very compelling statistical significance. There is a high probability that this study will meet its end points. seekingalphaDOTcom/article/1706552-cytori-therapeutics-independent-study-on-scleroderma-shows-great-results
Having said all this, we still have a capital issue in the short term that must be addressed.
The original independent study on this had great results:
The first FDA approved pivotal trial for Cytori and a long time coming.
"most likely shorted all the way down"? ...where did you that from? If he did want to reduce his exposure it would make more sense for him to sell out and not pay stock borrow fees to keep open a short against the box position. Plus, I'd expect that there would be some regulatory filings involved due to the size of his position. IMHO, By the nature of his agreement he is an investor not a trader. Anything is possible but I just don't see it. You're lashing out at everyone, not that I can blame you.
No mikeadd, I just don't think Athena results will have much bearing on the share price given the trial has been suspended, even if the data are strong. Potential Cytori investors will not bite regarding "potential" of a partnership in cardiology anymore, IMHO. We've heard that string along story too many times in the past to put any credibility into the possibility. Its "Show Me" time. The company is at a stage that they need clear signs of a revenue ramp to move shares higher, IMHO. They HAVE laid down a foundation for this with Lorem but they need to SHOW that execution is happening. Thankfully, execution of a ramp up in China, and 4 other countries, is in the hands of an entrepreneur with a track record of success and not with a management team and BOD that has lost credibility (new CFO excluded). My scenario above is a BEST CASE scenario only. Remember that KT Lim bought 8,000,000 shares at $3 each a little more than a year ago and he is both MOTIVATED and really #$%$ off.
Yes Roth, anybody who rode this to this level has been wrong. No doubt about it. However, as I have said on numerous occasions, the company needs to execute and they never were able to. They have a technology that could change the word but so far, management has failed miserably in converting it into shareholder value.
This post certainly be criticized as wishful thinking and I acknowledge this criticism up front. However, if you want to put on some rose colored gl#$%$es for a few minutes, this is a best case scenario for the company over the next 6 months.
1) Cytori obtains China approval before year end.
2) China approval triggers $5,000,000 payment from Lorem for required equipment purchases.
3) At the same time we hear a substantive update from Lorem/Cytori that convinces the market that revenue ramp is imminent in 2015 as Celution's make there way into China for the first time.
4) Shares move up to $.60-$1.00 range as a result.
5) On earnings call in February/March we hear that Okyanos is kicking #$%$ and contributing real revenues to Cytori. This reality contributes to the market's perception that patients will pay for effective Cytori Cell Therapy and that the China opportunity (and other Lorem territories) for revenues is real and imminent. Stock moves into $1.50 - $1.75. De-listing risk off the table.
6) With momentum building and the share price rising, the deal that Calhoun was working on (as per 8-K) comes to fruition, bringing in $10,000,000-$15,000,000. It is for a particular indication originating out of the EU. Stock now in the $1.80-$2.20 range as pressure from debt is pushed off by 8 months.
7) 1st Quarter 2015 conference call in early May 2015 confirms that commercial revenue ramp is under way. Shares climb to $3-$4 range as enthusiasm builds.
These are the personal views of WST and should not be used for your investment decisions. Furthermore, it should be noted that these views have been incorrect with regard to Cytori in the recent past.
Wall Street Titan
Nice find, These words caught my attention related to the Stroke Trial::
"The clinical study is being conducted in two parts: (1) a safety and dose escalation stage,
consisting of two dose cohorts including low dose and placebo and high dose and placebo
groups; and (2) a proof-of-concept of efficacy stage. Enrollment of part 1 has been completed,
preliminary data has been reviewed, and the independent safety committee has authorized
proceeding at the high dose level in part 2. The doses studied in part 1 were within the range of
expected efficacy based on the preclinical studies, and a review of the blinded part 1 efficacy data
provides a strong basis for establishing proof-of-concept in the 2nd part of the study."
Sentiment: Strong Buy
Nice summary, auz_boston. The table is set now let's go to dinner. Happy Thangsgiving.
Sentiment: Strong Buy
ohmtaxi Either you misinterpreted what I was saying or maybe I wasn't clear. I am saying that a single or double should suffice to meet the Japan's lowered bar of "show safety and demonstrate probable efficacy". Those are not my expectations. My expectations are for a double or triple with an smaller probability of a home run but I have no better idea than anyone else. UC, on the other hand, turned out to be a strikeout.
Sentiment: Strong Buy
lookin_forupside. I don't know exactly how the specific process will work with regard to gaining approval but my understanding is that it is a centralized process. Once you get the approval, all patients in the country are covered. That is a big advantage over decentralized Europe but of course it is only one country. Then the question becomes how much per procedure? Stroke is a big ticket expense for any health care system and there is no viable treatment after the first couple of hours. Multi-Stem, if approved, should get great pricing based on how much it can save Japan if it shows probability of efficacy.
This is huge news and puts Athersys on the cusp of a relatively short and inexpensive road to commercial revenues. However, let me point out again, so that no one can say I didn't warn them, there are two sides to this coin and we the stroke data to show enough for this to happen. No guarantees. Do your own DD.
Sentiment: Strong Buy
One of the KEY questions I've had about the new Japanese regmed legislation was whether conditional approval (based on the demonstration of safety and probable efficacy) would include reimbursement from Japan's health insurance system. This is a critical component and catalyst to the valuation of Athersys and other regenerative medicine companies. A few months ago I was getting conflicting views on this from leaders of the industry. Today, as the law takes effect, the answer has been provided in a press release from Mesoblast:
Key takeaways of the PMD Act for Mesoblast are:
Conditional product approvals will be based on existing Phase 2 trial results
demonstrating probable efficacy and safety with bridging studies in Japanese
Conditional approvals will allow sales of each product candidate for up to 7 years
Conditionally approved products will be covered by health insurance
Conditional approvals will cover allogeneic cell therapy product candidates
manufactured under GMP outside of Japan; and
Full approval is expected to require further confirmation of safety and efficacy in
a larger population.
Athersys has set the table for a ramp up revenues in the relatively short term. They don't need a home run in the Phase II stroke results to take advantage of this huge opportunity in Japan. A single or double should suffice at this point. Athersys already has extensive safety data. All they need to do is demonstrate "probably efficacy" and they can get reimbursed for ischemic stroke in Japan without a Phase III. You can bet that the recent changes to the primary outcomes of the stroke trial were designed to favorably position Multi-Stem for this conditional Japanese approval and the immediate revenues that go along with it. This could get VERY interesting. Do your own DD.
Sentiment: Strong Buy
For one, Athersys will be using a much higher dose. NBS did show good MACE data with lower doses.
"In 2010, we announced top line results from the Phase I study. The study results, based on four months of post-treatment patient data, demonstrate that MultiStem was well tolerated at all dose levels and also suggest improvement in heart function in treated patients. Highlights of the study include the following:
Administration of MultiStem was found to be well tolerated at all dose levels, and:
No clinically significant changes in vital signs, allergic reactions, or infusion-related toxicities were associated with MultiStem administration;
Each dose group showed improvement in mean left ventricular ejection fraction (LVEF), a measure of heart function, compared to baseline and relative to the registry group;
Patients in the 50 million dose group had a statistically significant absolute improvement in mean 4-month LVEF relative to baseline (9.8 percentage points, representing a 23.4% improvement over baseline, p
Sentiment: Strong Buy
Here are some differences and points between the NBS and ATHX heart trial for those interested:
-NBS autologous versus off-the-shelf for ATHX
-Dosing was much smaller in NBS autologous model (best results were at high dose of 20Mm cells). Athersys smallest dose in Phase I was 20 million cells. 50 million and 100 million cells where also dosed and Athersys also found dose related efficacy.
-NBS focused on STEMI, Athersy Phase I was also on STEMI patients - Phase Ii will be on Non-STEMI patients.
-Although both company cells are derived from bone marrow, cells are different.
Review Athersys Phase I STEMI here: athersysDOTcom/ami.cfm
Its all abut stroke results right now but I do find they Neostem results encouraging for Athersys.
Sentiment: Strong Buy
Its a small positive in a sea of negativity but it is cold hard cash. Does it mean they get a deal in the near term? I have no idea but there was that 8-K regarding contingent payments to Calhoun if certain capital raising deals were closed. On the other hand we've heard that talk for years. Still in the dog house until proven otherwise, I agree, but better than nothing.
I wasn't expecting any Insider buys, so this IS a positive:
200,000shs by COB RIckey
60,000shs by CFO Girao
When insiders step up with their own cash, especially given the uncertainty surrounding Cytori's financial position, it means something even if the value of the purchases are not huge. Is it a prelude to a non dilutive shoring up of the balance sheet? I hope so.