IMO CYTX's cell therapy is perhaps one of the very few that really works, because the harvested cells would still be alive in their natural environment. In other cases such as the STEM's method of harvesting stem cells, a lot of cells are damaged or transformed after many hours of processing.
For some reasons, DOV is not posting any more.
However WST is doing a great job in updating us. He also a link to the CYTX people. We should all appreciate his insight. Like many investors here, WST has his frustration with the present PPS in the presence of many recent PRs.
Mr. Hedge is a great technical person and makes great calls in his technical analysis.
Cytori is too small for Ruud Jona and cytori's business may not interest him. His backgoroud is all in much bigger international companies. Besides, he is based in Australia with a lot of business in Europe.
Hedrick's Letter to the Shareholders is a nonspecific road map for the company under his and Rickey's leadership. The road map starts with Athena and BARDA. From the BARDA press release, we are going to hear more details around the time of the stockholders' meeting. Saad indicates in his latest company presentation that CHINA approval of Celution may come around end of the year (I think he says Approval, but I think it is more likely Submission for Registration).
Stem cells clinical r/d projects may always be slow. This is a new medical field and It always takes time to finalize a protocol, IRB approval, patient screening, Case report form preparation, budget negotiation with the clinicians, etc.
Patient enrolment may be slow, as in many stem cell r/d projects. Could the extension of the timeline for option 1 to September 2016 be considered negative?
The BARDA notice must have received a few days ago, but it was not released to the public because of July 4. Someone knew this and held the PPS down to allow buying at 2.40. A lot of trading last few days around 2.40.
The BARDA penal consists of representatives from CDC and FDA! Very interesting indeed, because many people have questioned if CYTX's technologies are really valid. Now, the platform technologies have been reviewed under a microscope and approved by the real experts.
During Calhoun's time, company was not able to deliver promises, including the sales expectation during 4th Q, 2013. So Calhoun's departure was logical for a CEO with a very bad report card.
Based on Hedrick's letter to the stockholders, the company should have received a formal letter from BARDA re expansion of the BARDA contract from the base contract level to Option 1. Hedrick is saying that by the time the stockholders have received his letter, the company should have heard something.
Yet, there is complete silence, which is troublesome.
There are many possibility of the silence. 1. Formal letter has not been received, because the signoff has been delayed, because some key players are off during to July 4. 2. Option 1 is not granted fully and the company has to continue negotiating with BARDA on a better option. Remember it took quite a long time before the original BARDA award was granted 2 years ago.
There could be other reasons for this silence.
Has someone such as DOV and WST contacted the company recently and find out what has gone wrong?
BARDA meeting will be held next Tuesday, but we may not hear anything for a while.
SAAD's presentation at Jefferies does not shed any light. Unlike the past, CYTX appears to be very cautious this time around.
Saad reminds people to read the Forward Looking Statement; I think twice.
Saad indicates CYTX is always short of cash.
He indicates that the decision from BARDA can go either way and the consequence there after. Positive side: company may not need to raise more cash in the short term; the reverse is true if the decision is negative (IMO, some projects and personnel would be cut to conserve cash).
One thing seems to be positive in his presentation: product approval (? or is it registration?) in China is expected end of this year.
He is also talking about a possible partnership in Europe through sport medicine (?).
IMO Saad seems to be kind of jumpy or nervous in this presentation. I think he has not been this way before.
IMO CYTX will go to the next stage, but which option (there are 3 and there are differences in milestones and $ amount)? I think in Saad's presentation slides today, they are targeting a layout of options for 2014 and 2015, a rather aggressive plan. The question is would government buy such a plan, based on what has been accomplished. If not, there could be further discussion for a different plan ( thus more time before a final decision). For the initial award of the BARDA contract, it took more than a year of discussion and grant submission before approval. Could this happen again? Getting something out of the government often takes time.
IMO most people have not taken BARDA seriously, till it actually happens.
The June 10 meeting is a routine meeting to review what has been done comprehensively in the presence of BARDA higher ups and to plan for the next step. BARDA would not waste time to meet if the project has been progressing in the right direction .CYTX and BARDA have been working closely in this project (at least at the r/d level), according to the company. One can assume that progress from this phase of the project to the next level should be considered done deal. Besides, the dollar amount involved is not considered very big for either phase. (Of course, in the view of CYTX, the dollar figure for the next phase is big, because CYTX is still a very small company.)
IMO, CYTX's BARDA project will go on to the next phase. This not really a big deal, but for CYTX it is a big deal and it will have a big impact on the PPS.
Going beyond the next phase to the so-called pivotal clinical studies would be more challenging. Good clinical data is needed in the next phase, before BARDA would grant bigger dollar amount in broader clinicals.
If adipose-derived cell therapy really works in thermal burns, CYTX may become one of the first to get FDA approval in the regenerative med space.