Cytori Therapeutics, Inc. (CYTX) has received notification from the FDA that Cytori has provided additional information sufficient to support continuation of enrollment in its ATHENA cardiovascular trials. The FDA has agreed that the submitted data and protocol amendments support the fact that there are no subject protection concerns that preclude continuation of the trials.
The ATHENA trials have enrolled a total of 31 patients thus far but enrollment was stopped last May by the company based on meeting the trials’ internal stopping rules related to potential cerebrovascular events affecting both cell and placebo treated patients.
Based on consultation with the FDA, Cytori initiated a thorough safety review consisting of evaluating each adverse event in all of its previous and ongoing cardiovascular trials and conducted additional testing of its product and cellular output. In addition, Cytori implemented several protocol changes to enhance the safety of the trial procedures for patients. The FDA response to Cytori’s submission was received on October 22, 2014.
“Cytori is first and foremost focused on patient safety in all its endeavors, and we are pleased to have successfully navigated this issue. Such issues are not uncommon in development programs involving novel technology for a severely ill population,” said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. “Currently, we are assessing what this delay means for this particular trial and will provide an updated plan on our forthcoming quarterly investor call.”
Hedrik probably satisfied that the FDA allowed trial to resume and with no money to pay for trial, will ,say we are to pursue avenues that we can monetize quickly. We are going to follow our 31 patients , and then discuss the 5 patients that have been treated at Okyanos and the others that will be treated there and we will rely on that data. Not sure how that would be perceived. Thoughts ? How nice would it be to hear some real good news. Rather then, that, the bad news on Athena which has destroyed our shareholder value , and forced management to make a deal from complete position of weakness., is going to allow those investors (shysters) to double there money on Thursday. Cytori continues to be the golden goose for anyone other then long term holders. I would think that Hedrik would have prepared for this announcement and be anxious to give some colour tomorrow as opposed to next quarterly report. Guess that is what is meant by improved communication with shareholders. Guess if you waited 2 months to tell your shareholders that you halted a trial,no harm in making them speculate about what is going on. How about a better scenario and announcing something major from Japan,or China, or Lorem or anywhere.
This is great news but so much damage has been done through shortsightedness, mismanagement and bad luck on Athena. Is there someone out there willing to put up the money and partner with Cytori on cardio? We've heard promises before that never materialized but if the data are compelling maybe someone will step up, be it a public company, large investor or the CIRM, which has invested billions in the area but has never given California based Cytori a single dime.
BTW, Jason Kolbert still projecting EPS $.60 in 2015 and $.09 in 2016 based on BARDA monies.
Sabby and others who participated in the rape of Cytori shareholders may be the sellers of stock because they still get to keep the upside through the free warrants. Nonetheless, this is good news for the company. Just think how bad it would have been if the FDA gave them a hard time. With Okyanos up and running and BARDA underway what we need is some substantive progress from KT Lim. From a business perspective, things are looking up but we still have the balance sheet to deal with. We need a substantial partnership infusion on something.
The following user(s) said Thank You: mtpinman, kekzy, d9dozrman
Totally agree on Sabby...he wants his money back and will gamble with the warrants. JK's note today a aid in that venture.
Also agree on the balance sheet still a major issue.
Lim a wild card who will buy some equipment but actual ramping of therapies still seems 2 years away to me...at least !!!
The rest still likely small potatoes for now....so we are again left praying for a partnership ? Still amazes me how such a promising science fell so far.
Incredible volume...lets hope we make a bit of progress this afternoon on the PPS.
as the FDA approved ATHENA there was no need to hold on to the shares anymore. I would love to have known how bad the dilution would have been had they not done so ........... always nice to know how costly management incompetentence could have been !!.
True, the volume looks impressive but as you say the value is peanuts. Sabby/Maxim/Roth proxies no doubt shorted all the way down so they not only get their money back by selling their new shares ......... they also book their profits from their short positions (wonder who the buyers are ????!!!!!!).
These rapists are not finished yet. They are profit maximisers with a strategy that has seldom involved being TRUE advocates for a company's advancement. The warrants provide them with the ability to short the stock at any time without great risk as they are backstopped at the 0.57 strike price. As they have privileged access to management due to their dominant equity position they will always have better info about the companies prospects/probems...........with the added benefit of Cayman Islands confidentiality, and circumvention of laws governing reporting requirements for major shareholders,......... not to mention privileged access to any additional equity placements undertaken by CYTX in the future (God forbid that they be treated like us, older shareholders), we can expect further fun and games.
There is only one solution to this problem ........ performance by management ......... our new date rapist co-shareholders will make out like bandits ....... but maybe we make some money also
Past performance is no guarantee of future results ........... hopefully this hold true for management performance also, not just mutual fund disclaimers. They can't do much worse ...... can they ????
The following user(s) said Thank You: rothco619, d9dozrman, fatboy
How can you count on this management when their paymasters have complete control of the enterprise? The only hope is for the science to have such success so as to create an avalanche of positive outcomes. Then they will ride it as hard as they can. Those who stay can hang onto the coat tails. Not a promising future but better than what was last week.
agree with you guys fat and long. imagine if our new owners decided to actually make a go of it. take the technology and put it in the hands if experts before this team bankrupts the company. how many times do you need to be kicked in the head to get it. get top notch ceo to run the company who understands the art of the deal,and has a history of success with a company of this type. finish the cellution device and be ready to produce it in anticipation of all the demand that will be generated from Japan supposedly in the near term. rickey should even be a bit annoyed that he has been the only insider that has bought any stock