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TOPIC: FDA Meeting

FDA Meeting 01 Dec 2017 10:06 #10684

  • franshei
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I think a FDA meeting has been scheduled or being held (as early as today).

There is a case for filing eligibility, (Hedrick has mentioned the reasons). The FDA decision may depend on the need and safety issues, as well as compromised conditions/limitations. Most people believe the FDA would request a phase 3 trial just in diffuse cutaneous scleroderma.

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FDA Meeting 02 Dec 2017 07:35 #10685

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Yes- just as a reminder- a phase 3 or better pivotal PMA is what the Company also expects- they provide two options:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

FDA Meeting 02 Dec 2017 12:08 #10686

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There was someone that got filled for about 400K shares around the $0.325 area
If you look at YAHOO volume it was over 1 million shares but if you look at DOV's (since his name has been recently brought up) naked short site, volume was 316K with over half of that as short volume..

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FDA Meeting 04 Dec 2017 09:07 #10688

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Franshei --

Is this another of your speculative guesses from way far out in left field? Perhaps you can provide some factual context to support your posts in the future?

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FDA Meeting 04 Dec 2017 10:31 #10690

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waddlingwillbologni wrote: Franshei --

Is this another of your speculative guesses from way far out in left field? Perhaps you can provide some factual context to support your posts in the future?


Waddle-

My name is not Franshei- but I would like to remind you, that this Board is all about speculations and not just only facts, otherwise things would become quite boring soon.

Just those speculations should be reasonable- and in my view Franshei´s speculations are reasonable. The facts supporting that are that-


  • 1. Cytori stated in the Q2 call in August that they were almost done completing the complete analysis of the STAR data and could file the meeting material soon
  • .


  • 2. General experience with requesting meetings like that with the FDA and getting a date, tend to require a 3-4 month "being patient" period.

  • I am expecting something in December also- but am not very optimistic as to its outcome.

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    Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

    FDA Meeting 14 Dec 2017 07:26 #10766

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    I personally think the FDA meeting has been held - in which CYTX is making a proposal for a PMA filing. But, FDA would take almost a month after the meeting to make a decision: filing or more clinical trials. Usually, when there is a clear decision of no filing, the FDA decision is almost immediate (as in a recent case with VCEL - couples of days after the meeting).

    PS Rodney: I did ask Taigo Girao about this FDA meeting very recently and his silence on this topic leads me to believe that the discussion is ongoing.

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    FDA Meeting 14 Dec 2017 10:27 #10769

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    Re FDA again
    CYTX comes to the meeting with a pre meeting submission and scleroderma experts. The purpose of the meeting is pre PMA submission. On hand they have the latest STAR data and sclerodec I data and a proposal for limited claims just for diffuse cutaneous sclerodmera and a plan for phase 4 trials to expand the claims.
    Hedrick has mentioned many times that sclerodec 2 would be supportive (universal experiences). The only way that he could make such a statement before the FDA medical officers is that Hedrick has some sclerodec 2 prelim information.
    One thing that I am puzzling is: STAR does not really end with 48 week data readout. There is always followup, since cell therapy takes a long time to become effective. The FDA would certainly asks for followup data if available (particularly for the diffuse cutaneous scleroderma). Maybe this data is still being collected (we are only 5 months from the late July STAR readout - one or two months to go?).
    At any rate, there must be a lot of things ongoing with the FDA meeting and STAR/Sclerodec 2.
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    FDA Meeting 14 Dec 2017 10:37 #10771

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    With all the data and a FDA meeting scheduled why did the CFO invest only $1,000 in the RO ?
    Why did the BOD invest so little ?
    CEO invested the most...$9,000.

    I think these are bigger questions to the insiders knowledge.

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    FDA Meeting 14 Dec 2017 10:49 #10773

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    myownhedgefund wrote: With all the data and a FDA meeting scheduled why did the CFO invest only $1,000 in the RO ?
    Why did the BOD invest so little ?
    CEO invested the most...$9,000.

    I think these are bigger questions to the insiders knowledge.



    Hmm - that's just what Hedrick and his group need is to wind up with a class action suit for trading on insider knowledge - they will get their options shortly and these people are not wealthy enough to have bought any sizeable amount anyway that would nearly approach the benefit of their stock options.

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    FDA Meeting 14 Dec 2017 11:02 #10774

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    myownhedgefund wrote: With all the data and a FDA meeting scheduled why did the CFO invest only $1,000 in the RO ?
    Why did the BOD invest so little ?
    CEO invested the most...$9,000.

    I think these are bigger questions to the insiders knowledge.


    Good point Hedge but I have one question, wouldn’t they need to be very careful in going all in on the RO if they had insider knowledge on this? If Franshei’s hypothetical turned out to be true, in my layman’s opinion, seems like they would be risking an insider investigation.
    I just saw RS beat me to the draw on this one but I’ll let the post stand.

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    FDA Meeting 14 Dec 2017 12:05 #10775

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    “Maybe this data is still being collected (we are only 5 months from the late July STAR readout - one or two months to go?

    What are you implying here Franshei, is there normally a time limit that the FDA must respond on trial results?
    I remember from my dealings with MELA, there was a very bad relationship between MELA and the FDA, there seems to be a much better working relationship with Cytori and the FDA.

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    FDA Meeting 14 Dec 2017 12:32 #10776

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    RS and b7
    Your over thinking the word "know"
    You can have the same data set avail. to everyone and have different interpretations. One doesn't have to travel any further than the Raccoon Lodge to see that !
    Besides if you can buy 1 share you can buy 1 million shares. There is no such thing as a little insider trading...LOL
    I also find the suggestion that limits on buying were due to the fact that they would soon be getting free options. Now this has the bigger ring of thievery even though legal. It's also amusing that some suggest the FDA news could before such awards.

    No, to me, the most logical conclusion is at $0.3333 for preferred stock and warrants, it had little appeal as a investment for the previously mentioned persons..

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    FDA Meeting 14 Dec 2017 14:17 #10778

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    myownhedgefund wrote:
    No, to me, the most logical conclusion is at $0.3333 for preferred stock and warrants, it had little appeal as a investment for the previously mentioned persons..


    What other conclusion could there be for someone that recently sold 96% of their position in CYTX. LOL

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    FDA Meeting 14 Dec 2017 14:28 #10779

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    ***What other conclusion could there be for someone that recently sold 96% of their position in CYTX. LOL***

    ...and honestly posted it !!!!!!

    CYTX has fallen quite a bit since then.

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    FDA Meeting 14 Dec 2017 16:31 #10788

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    myownhedgefund wrote: ***What other conclusion could there be for someone that recently sold 96% of their position in CYTX. LOL***

    ...and honestly posted it !!!!!!

    CYTX has fallen quite a bit since then.



    You are greatest - better than Ali - LOL

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    FDA Meeting 14 Dec 2017 20:53 #10791

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    Rodney
    Tiago Girao has been away. Upon his return, he replies my inquiry. It looks like my previous assumptions maybe very close to reality: meeting has been held and the company is waiting for some kind of decision in writing. There have been some sporadic buying spikes (Hedge calls them short coverings)- I think someone knows that the meeting has been held, but no one really know what would be the final outcome (not even the company, but people who are in the meeting may have better hints). Actually, during my times in the pharma industry, I was able to read the outcome quite easily- all would depend on the strength of the argument (FDA people would usually sit there quietly and ask a few questions here and there - they would not make a decision outright, unless it is obviously negative, as in the recent VCEL FDA meeting).
    Note: Filing a PMA or NDA does not mean approval is at hand, because FDA would do their own analyses and balance out risks and benefits. There is no clear black and white, particularly in marginal therapies.
    PS In the case of VCEL, they have a number of death reported in their cardio studies. As usual, the company claims these deaths are not drug related. But, in the view of the FDA, this is a safety issue.
    PS2 FDA can be very political in making certain decisions. For a small niche claim in new science, they may make some very surprising decision to open door for more filings. We shall see.
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    FDA Meeting 15 Dec 2017 14:05 #10792

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    franshei wrote: Rodney
    Tiago Girao has been away. Upon his return, he replies my inquiry. It looks like my previous assumptions maybe very close to reality: meeting has been held and the company is waiting for some kind of decision in writing. There have been some sporadic buying spikes (Hedge calls them short coverings)- I think someone knows that the meeting has been held, but no one really know what would be the final outcome (not even the company, but people who are in the meeting may have better hints). Actually, during my times in the pharma industry, I was able to read the outcome quite easily- all would depend on the strength of the argument (FDA people would usually sit there quietly and ask a few questions here and there - they would not make a decision outright, unless it is obviously negative, as in the recent VCEL FDA meeting).
    Note: Filing a PMA or NDA does not mean approval is at hand, because FDA would do their own analyses and balance out risks and benefits. There is no clear black and white, particularly in marginal therapies.
    PS In the case of VCEL, they have a number of death reported in their cardio studies. As usual, the company claims these deaths are not drug related. But, in the view of the FDA, this is a safety issue.
    PS2 FDA can be very political in making certain decisions. For a small niche claim in new science, they may make some very surprising decision to open door for more filings. We shall see.


    Franshei, great post - I think that we hear some news before y/e!

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    FDA Meeting 15 Dec 2017 14:56 #10794

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    Rodney
    All people are expecting the death of STAR. if the FDA would allow CYTX to file for a limited claim, this would be a big surprise.
    XOMA has a phase 2 failure and its biggest backer Baker Brothers sells its entire holding. The in the following months, something happens and the stock goes from under $ 3 to $ 30! Baker Brothers has representatives sitting on the BOD and still they have made a mistake in selling.

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    FDA Meeting 15 Dec 2017 15:08 #10795

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    franshei wrote: Rodney
    All people are expecting the death of STAR. if the FDA would allow CYTX to file for a limited claim, this would be a big surprise.
    XOMA has a phase 2 failure and its biggest backer Baker Brothers sells its entire holding. The in the following months, something happens and the stock goes from under $ 3 to $ 30! Baker Brothers has representatives sitting on the BOD and still they have made a mistake in selling.


    Franshei, CYTX is due for some good luck and one never knows how this whole situation can quickly turn for the better!

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    FDA Meeting 20 Dec 2017 10:02 #10822

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    Rodney
    1. Based on y correspondence with Tiago Girao, CYTX is waiting for an official notice before a PR. The meeting was held. It seems to take along time for the release of the official letter - it means the FDA has to meet internally before a final decision, during this time when they are wrapping up business for the year (busy time). If it is a rejection for ling, the FDA decision should be very quick.
    2. There is a very high political sense behind the need for a treatment for scleroderma. Cell therapy works and it would work even better in combination with cytoxan for advanced illness- oncologists at Johns Hopkins and Northwestern want something for this illness and they cannot combine the treatment with stem cells beyond experimental stages, unless this cell therapy is approved, Thus the FDA is under a lot of pressure to approve something, while the procedure is safe and clinically effective (the statistics maybe cosnidered Ok for regenerative medicine)

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