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TOPIC: FDA meeting

FDA meeting 16 Mar 2018 16:17 #11526

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On March 13, 2018, Cytori Therapeutics, Inc. (the “Company” or “Cytori”) met with the U.S. Food and Drug Administration (“FDA”) to discuss the
outcome of the STAR (Scleroderma Treatment with Celution Processed Adipose Derived Regenerative Cells) clinical trial and the Company’s plans for Habeo Cell
Therapy. The STAR trial was a prospective, double-blind, randomized, multicenter, parallel-group Phase III pivotal study assessing the safety and efficacy of a
single, subcutaneous administration of Habeo Cell Therapy, a Cytori Cell Therapy based candidate, into the fingers of patients with hand dysfunction due to
scleroderma. At the meeting, the FDA provided verbal feedback that was generally consistent with the Company’s belief that a clinical trial focused on more
severely affected diffuse systemic sclerosis patients could be an appropriate next step given the results of the STAR clinical trial. The Company intends to finalize
meeting minutes and pursue additional dialogue with the FDA to clarify the parameters and key aspects of a potential follow-on clinical trial of Habeo Cell Therapy
before making financial commitments to further pursue a follow-on clinical trial.
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FDA meeting 16 Mar 2018 16:54 #11527

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No surprise there.
How big this trial must be will be the driver now let alone who the heck pays for it.

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FDA meeting 16 Mar 2018 17:14 #11529

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What trial? My prediction is that they will never run it. Data wasn't that compelling.

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FDA meeting 16 Mar 2018 17:44 #11530

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mtpinman wrote: On March 13, 2018, Cytori Therapeutics, Inc. (the “Company” or “Cytori”) met with the U.S. Food and Drug Administration (“FDA”) to discuss the
outcome of the STAR (Scleroderma Treatment with Celution Processed Adipose Derived Regenerative Cells) clinical trial and the Company’s plans for Habeo Cell
Therapy. The STAR trial was a prospective, double-blind, randomized, multicenter, parallel-group Phase III pivotal study assessing the safety and efficacy of a
single, subcutaneous administration of Habeo Cell Therapy, a Cytori Cell Therapy based candidate, into the fingers of patients with hand dysfunction due to
scleroderma. At the meeting, the FDA provided verbal feedback that was generally consistent with the Company’s belief that a clinical trial focused on more
severely affected diffuse systemic sclerosis patients could be an appropriate next step given the results of the STAR clinical trial. The Company intends to finalize
meeting minutes and pursue additional dialogue with the FDA to clarify the parameters and key aspects of a potential follow-on clinical trial of Habeo Cell Therapy
before making financial commitments to further pursue a follow-on clinical trial.


News is as expected - HF making a big deal out of nothing imo!

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FDA meeting 16 Mar 2018 17:49 #11532

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Agree WST...as I posted on YMB...this may all get shelved.

Agree RS...they have nothing !

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FDA meeting 17 Mar 2018 09:48 #11542

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I’m by no means an expert in this stuff but I don’t see them shelving it until the French data comes in by July. Agree, not much progress in US will take place until we see how the French data comes out. If it’s bad, say adios Scleroderma.

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FDA meeting 17 Mar 2018 12:00 #11544

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b7
The point is timing...they will be out of cash by then.
Therefore, imho, they will need to know the cost of a U S, FDA trial before they attempt to raise funds or simply shelve it if it will be too expensive and worry about it later. Azaya is their #1 priority. Clear as can be in the last call and most if not all funds raised will go to this first.
Right now the French trial may advance things in the EU and help in the design should a US trial finally, if ever, go forward....but again this is all going to be after the have to deal with the cash issue and the R/S issue for September 4, 2018.

This is a big reason why I am curious how they handle the annual meeting.
How much will they tip their hand ?
Hmmm...good heading for a post under the annual meeting thread...maybe later.

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FDA meeting 17 Mar 2018 20:07 #11545

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If the FDA was truly supportive of helping regenerative medicine develop efficiently and in a cost effective manner they could do the following:

Let the Scleredac 2 trial data be merged with the STAR data. Specifically I suggest that only the diffuse patiens from both trials be evaluated. This would entail simply taking another reading of the of the Cochin Hand Score at the 6 month mark. As Scleredac 2 is a multicenter trial this would add statistical validity for the trial data. It would not affect the findings of the original Scleredac 2 trial protocol/analsis.

It would also be helpful in confirming the srength of the diffuse data for each individual trial by comparing the two trials against each other prior to pooling the data.

Conceivably if the FDA was not prepared to accept such an analysis ie. pooling diffuse data ........ perhaps the European/French regulatory authorities would no be so anal.

In any case the pooling of the data in and of itself will deermine wheher an adiional rial is warraned and he size/powering requred. Personall I do no believe anoher rial should be warraned if he pooled daa is saisicall significan. Also such data would be compelling for any potential suitor. Wheher CYTX management is competent to take advanage of such a situation is ...............:cry: :really: :KO:

I want to hear about an IIS study into treating pressure sores in hospitalised patients . IT IS A NO BRAINER. Hedrick, pull your finger out and ring a few of the larger university- teaching hospitals that have access to the Celution device and suggest it. If you don't have the time give me a ring and I will be happy to coordinate it for you, GRATIS !!!!!

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FDA meeting 18 Mar 2018 01:59 #11546

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I agree that all companies would love to be able to cherry pick around the globe to get their products through the regulatory processes of each country. Just doesn't work that way and I am not sure it should.
Its just too late for the rest of the indications...at least of anything meaningful.
Annual Meeting follow lodge members....this should be our focus imho. How will they run it with their again mounting problems ? What will they address and what will they ignore ?

As a secondary item, who keeps supporting $0.30 ? Will it continue and why ?

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FDA meeting 19 Mar 2018 12:43 #11552

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rongside wrote: If the FDA was truly supportive of helping regenerative medicine develop efficiently and in a cost effective manner they could do the following:

Let the Scleredac 2 trial data be merged with the STAR data. Specifically I suggest that only the diffuse patiens from both trials be evaluated. This would entail simply taking another reading of the of the Cochin Hand Score at the 6 month mark. As Scleredac 2 is a multicenter trial this would add statistical validity for the trial data. It would not affect the findings of the original Scleredac 2 trial protocol/analsis.

It would also be helpful in confirming the srength of the diffuse data for each individual trial by comparing the two trials against each other prior to pooling the data.


I did read the CC transcript again tonight. Sounded that Hedrick was getting cosey again with Andy da Silva- probably since Riley was doing that Chinese Conference-

anyway- I think Scleradec II and STAR could still surprise some folks- especially on the 12 week handscore endpoint and what reulatory agencies can do with that-:whistle:

I think the key point to highlight beyond that point is the readout is at 12 weeks. And as you know, it seems from the STAR data that the primary impact was greatest at 12 weeks. So it'll be interesting to evaluate that data in a randomized controlled trial with the primary endpoint that reads out at 12 weeks in terms of hand function and the other secondary endpoints. And recall, in the combined group in the STAR trial, I believe we did achieve statistical significance in the primary to secondary endpoints at 12 weeks in the mixed group of patients. I'll just point that out.

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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 19 Mar 2018 23:50 #11557

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Here's hoping that the data from Scleredac 2 is positive, and that management can leverage it effectively. As regards China presentation/presence I wonder how that will play out given we have sold rights to Lorem Vascular.

Perhaps they could do a deal and sell/transfer rights to someone who is more involved in the sector. Could you imagine a chinese listing?

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FDA meeting 20 Mar 2018 08:26 #11558

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rongside wrote: Here's hoping that the data from Scleredac 2 is positive, and that management can leverage it effectively. As regards China presentation/presence I wonder how that will play out given we have sold rights to Lorem Vascular.

Perhaps they could do a deal and sell/transfer rights to someone who is more involved in the sector. Could you imagine a chinese listing?


Yes- let´s hope they can do something with the the PRIMARY ENDPOINT 12 weeks i.e. 3 MONTH data- of Scleradec II.



We should not forget, that besides the WHOLE group (88 patients) the p value was 0,029 at 12 weeks, but for the diffuse group even better -0,008. I know the statement for diffuse was "trending towards statistical significance" at 48 weeks. To me more important- clearly statistically significant at 12 weeks.

Combining that with Scleradec II which has 12 weeks as PRIMARY ENDPOINT should be fun. :grin:

It seems that Lorem Vascular is still around:



but no- to be honest, I hope I do not get involved in China.
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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 20 Mar 2018 08:54 #11559

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What's your take on the timing of the 12 week data release...other than Hedricks broad second half of the year.

From what I have read the 12 wk data wont be separately released from the full trial...after the 6 month follow-up.
There in lies the problem if this will help before another round of dilution.

The other issue is this too will be a mixed population of patients....not just diffuse patients...so it should give a snap shot in the break out but will the headline get us where we want to be with the general public ? By general public I mean both investor and patient populations.

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FDA meeting 20 Mar 2018 09:19 #11560

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myownhedgefund wrote: Fas
What's your take on the timing of the 12 week data release...other than Hedricks broad second half of the year.

From what I have read the 12 wk data wont be separately released from the full trial...after the 6 month follow-up.
There in lies the problem if this will help before another round of dilution.

The other issue is this too will be a mixed population of patients....not just diffuse patients...so it should give a snap shot in the break out but will the headline get us where we want to be with the general public ? By general public I mean both investor and patient populations.


Timing? Didnt they report full enrollment early January?

I do not know- but if you have a clinic with a primary endpoint which looks very "achievable" in view of its sister trial- I wouldnt start fucking around with dates or what have you- just report SS in the primary endpoint, and I will be happy. :grin:

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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 20 Mar 2018 10:38 #11561

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***Timing? Didnt they report full enrollment early January?***

Exactly correct !
Full enrollment PR was released late Jan. 2018.
My point was in the release of the data.
I say most likely September for both primary and secondary endpoints. If they are lucky maybe late August but it doesn't help on the cash burn front.
Something else has to fund them BEFORE this data will becomes available. What that is can be debated of course.

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FDA meeting 20 Mar 2018 11:17 #11562

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myownhedgefund wrote: ***Timing? Didnt they report full enrollment early January?***

Exactly correct !
Full enrollment PR was released late Jan. 2018.
My point was in the release of the data.
I say most likely September for both primary and secondary endpoints. If they are lucky maybe late August but it doesn't help on the cash burn front.
Something else has to fund them BEFORE this data will becomes available. What that is can be debated of course.


You are probably right about late August/early September for both 12 and 24 weeks data, although this brings up the issue again of certain people knowing more half way.

Things will get quite interesting- since there are still a lot of factors to be considered (besides the Swiss)- even Kolbert has some "Hedge-like insights.." :grin: :grin: :grin: , which Girao answered as follows (rather interesting- his fighting spirit)

And, Tiago, can you talk with me a little bit about the financing strategy associated with the company? With the $10 million cash balance, given kind of what you see as the catalysts, how are you going to make that cash last, and kind of what's the plan going forward?

Sure, Jason. Certainly, we don't have as much cash as we would like to have. That's a point. (:grin: ) That said, we have a few things coming up that we are working on. That includes some potential milestones from current partners that we have that are coming due. We have activities related to business development that I can't really precisely tell you when it's going to happen, but we are having ongoing dialogues to partner 1 or more of our assets that could bring in some cash, and we will continue to look at ways that are as friendly as possible to shareholders to leave money. We have not given up. We are not giving up. And we will move this company forward. We have a lot of assets that we think are valuable and a lot of things that we can get to patients that are in need.

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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 20 Mar 2018 11:37 #11565

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fas wrote:

myownhedgefund wrote: ***Timing? Didnt they report full enrollment early January?***

Exactly correct !
Full enrollment PR was released late Jan. 2018.
My point was in the release of the data.
I say most likely September for both primary and secondary endpoints. If they are lucky maybe late August but it doesn't help on the cash burn front.
Something else has to fund them BEFORE this data will becomes available. What that is can be debated of course.


You are probably right about late August/early September for both 12 and 24 weeks data, although this brings up the issue again of certain people knowing more half way.

Things will get quite interesting- since there are still a lot of factors to be considered (besides the Swiss)- even Kolbert has some "Hedge-like insights.." :grin: :grin: :grin: , which Girao answered as follows (rather interesting- his fighting spirit)

And, Tiago, can you talk with me a little bit about the financing strategy associated with the company? With the $10 million cash balance, given kind of what you see as the catalysts, how are you going to make that cash last, and kind of what's the plan going forward?

Sure, Jason. Certainly, we don't have as much cash as we would like to have. That's a point. (:grin: ) That said, we have a few things coming up that we are working on. That includes some potential milestones from current partners that we have that are coming due. We have activities related to business development that I can't really precisely tell you when it's going to happen, but we are having ongoing dialogues to partner 1 or more of our assets that could bring in some cash, and we will continue to look at ways that are as friendly as possible to shareholders to leave money. We have not given up. We are not giving up. And we will move this company forward. We have a lot of assets that we think are valuable and a lot of things that we can get to patients that are in need.


Fas, I recall being encouraged by Tiago's response - also, great to see some fire in the belly - "We have not given up. We are not giving up. And we will move this company forward." All just words, but a reason for hope.

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FDA meeting 20 Mar 2018 11:39 #11566

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Well, we have heard all of this before but yes the fighting spirit is due to the fact they are really trying hard just to survive.
As we know BARDA has a small single digit profit built in....so I believe starting the trial they get some milestone...ok a few $...not enough imho. That's the existing partner.
What else and if something happens at what cost ? This we dont know but I expect we wont be happy with what we either give up cheaply or another dilutive round.

Above said...$0.30 still holds.
Why ????

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FDA meeting 20 Mar 2018 12:37 #11568

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myownhedgefund wrote: Well, we have heard all of this before but yes the fighting spirit is due to the fact they are really trying hard just to survive.
As we know BARDA has a small single digit profit built in....so I believe starting the trial they get some milestone...ok a few $...not enough imho. That's the existing partner.
What else and if something happens at what cost ? This we dont know but I expect we wont be happy with what we either give up cheaply or another dilutive round.

Above said...$0.30 still holds.
Why ????

/


"Above said...$0.30 still holds.
Why????"

You don't really think that the Swiss and other large buyers that were convinced to buy into the RO @ .33 were actually going to lose money - this game has yet to play out imo.

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FDA meeting 20 Mar 2018 13:56 #11571

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RS
While a straight equity appreciation model is a possible motive as is Fas' secret EU axis you shouldn't be so linear in your thinking.
Are you telling me Sabby lost money in all of their participation of Cytori financings ?
Many ways to skin a cat !!!

OT: BTW...what do you think of ARNA popping to its 52 week high then pulling back 5 points ?
That sounds like a skinned cat to me...LOL

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