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TOPIC: JP Morgan Conference 1/9

JP Morgan Conference 1/9 03 Jan 2018 13:32 #10845

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Rodney

Looks like Hedrick will make a presentation.
1. He needs to present Scleroderma as a platform for the cell therapy. He never presents new news in the meeting, so why no news re FDA meeting.
2. If there is real new news, CYTX would not hold back. So the silence means FDA may need another phase 3 beyond STAR (?) for approval (??).

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JP Morgan Conference 1/9 03 Jan 2018 14:03 #10846

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franshei wrote: Rodney

Looks like Hedrick will make a presentation.
1. He needs to present Scleroderma as a platform for the cell therapy. He never presents new news in the meeting, so why no news re FDA meeting.
2. If there is real new news, CYTX would not hold back. So the silence means FDA may need another phase 3 beyond STAR (?) for approval (??).


Franshei, Friday's action suggested that news could be forthcoming, but this week there has been less than a follow through - not sure what to expect at this point.

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JP Morgan Conference 1/9 03 Jan 2018 16:50 #10847

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franshei wrote: Rodney

Looks like Hedrick will make a presentation.
1. He needs to present Scleroderma as a platform for the cell therapy. He never presents new news in the meeting, so why no news re FDA meeting.
2. If there is real new news, CYTX would not hold back. So the silence means FDA may need another phase 3 beyond STAR (?) for approval (??).


Whatever information they have from the FDA, be it phase 3 required or whatever, it’s my understanding that they have to make it public within a certain time frame after receiving the FDA’s response.

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JP Morgan Conference 1/9 03 Jan 2018 18:39 #10848

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Rodney and B7
If CYTX has the FDA blessing to file a limited PMA, this is very, very big news. CYTX would not hold this information back. The stock would have rocketed. Yet, we have heard nothing.
Unless, the results of the FDA meeting lead to more discussion, submission of more data and even more work, including preparation of another phase 3 /or a phase 4 (I think phase 4 protocol is unlikely at this stage) protocol for activation later on this year. If this is the case, CYTX does not have to release a PR, till the whole situation is more materialized.
We may not have any news before the JP Morgan Conference.It may come late till the morning of the conference (this situation happened before).

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JP Morgan Conference 1/9 04 Jan 2018 06:35 #10849

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Franshei, if the "FDA had given the blessing to file a limited PMA", is it your opinion that CYTX would have already received that blessing or could it still be forthcoming?

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JP Morgan Conference 1/9 04 Jan 2018 15:25 #10854

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Rodney

What is the FDA plan from here is unknown to outsiders. For a limited claim, it is very possible that FDA wants more followup data -they may have asked for the 18 month data, which should now be available/or almost available. Since the 12 month data is so close to be statistically significant and if Habeo REALLY works in diffuse cutaneous scleroderma, the 18 month data would be the key for the FDA make a move,without another phase 3 trial.

I think if my assumptions are correct, a FDA material decision would still take some time to reach.
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JP Morgan Conference 1/9 04 Jan 2018 17:52 #10856

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***I think if my assumptions are correct, a FDA material decision would still take some time to reach. ***

Ugg, more wasted cash burn.
Think CYTX will be fishing for the next financing at JPM ? Surely they wont want common but what about working on a partial sale ?

Ugly street seems to be a 6 lane highway with no off ramps in sight for Cytori

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JP Morgan Conference 1/9 04 Jan 2018 18:19 #10857

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An FDA decision to allow CYTX to file a limited PMA would be somewhat like a Hail Mary play. Allowing the filing of course is not the same thing as giving approval. However, I do feel that there is substantial proof of efficacy in the diffuse scleroderma population to warrant approval. If 18 month data is enough to push it into statistical significance that would be great. Conceivably they may require validation from merging the the 12 month Scleradec II data for diffuse patients to increase the sample size..... who knows?. The truth though is that CYTX does not have the funds (or skill set) to bring this to market without a partner. Perhaps selling the rights for all indications in Japan may provide the funds necessary to take us over the finish line.

Should approval be given, even on a conditional basis it would be a huge win that would provide the autologous model much needed validation. It would also leapfrog us ahead of virtually everbody else in the regenerative space. Given the autologous nature of our product it would be an almost immediate competitor to every allogeneic product that gets approval (eg. Tigenix-fistula).

The question is whether the FDA wants to be seen to be proactive in the regenerative space. By approving a device such as Celution it sets the bar of what is acceptable from a cGMP basis and provides a device for the broader market of SVF clinics. It would also make it easier to monitor usage (volume and applications). Of course we would still have the elephant in the room issue of how do you price the consumables for what is effecively the same product which is being used in an approved indication such as scleroderma or cosmetic surgery? This for me is a HUGE issue. Given the complexity of reimbursement issues alone, it raises questions that would make this a major undertaking for even well capitalised BP/BB.

A new year starting with a posiive post ?. Some people never learn :bash: .................. Happy New Year :bye:
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JP Morgan Conference 1/9 04 Jan 2018 18:31 #10858

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Hedge
1. The JP Morgan presentation for CYTX appears to be 1/8 (Monday), not 1/9.
2. I am sure Hedrick has to make the company visible.
3. I really think the 18 month data for STAR is being gathered or it has already been gathered. From Hedrick's November CC, Cytx went to FDA for a limited claim in diffuse cutaneous scleroderma and we all know Habeo at 24 month is safe and clinical effective (the statistics sit at borderline). I think CYTX has a good case to get the FDA on their side for this medical condition (moderate to serious, but not life threatening with organ involvement - for the very serious condition, CYTOXAN should be used). But, FDA, I believe, needs the 24 + 6 month data to show that Habeo really works. (I have similar situation with the FDA.).
4. As long as Cytori Cell Therapy is part of CYTX, the company needs a FDA approvable indication.
6. However, we would still be in the poor house with just the cell therapy. Our revenue to support the company is AZA/Cytori Nanomedicine - Drugs. Even if we would market in EU through a distributor, the revenue will far exceed what John Harris can do in Japan. I think the initial ATI 0918 EU registration filing will come around mid 2018 with approval in early 2019.
7. Still the company would need more cash less a year from now. How would this be done? I think you have some good clue, but a lot of things can happen in the next 6 months- Sclerodec 2 and hopes for an EU registration filing, news from Japan re urinary Incontinent study, ......(you can fill in the blank).

Now with Sabby backin and John Kerr's continuing faith in CYTX Nanomedicine, let us hope we have a good first half of 2018. better than it was in the past 6 months.
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JP Morgan Conference 1/9 04 Jan 2018 19:37 #10859

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rongside and franshei

Extending the timeline to get to stat sig may be a option....but then who else gets to do it ?
That is the sticky part as everyone will want a me too clause added to their reported results.
What they have reported to date doesn't get them over the line imho and t Hedrick wont shine a very bright light on the issue beyond what has already been stated at JPM.

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JP Morgan Conference 1/9 04 Jan 2018 20:15 #10860

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Hedge

As in the French studies, almost all cell therapy studies have longer term followup. It is the nature of cell therapy. The multicenter HIH cell therapy plus cytoxan is also a clear example. FDA knows better than us.They also know the impact of placebo effects in the studies - our body is regenerative in nature and in many mild/moderate medical conditions, the body may take care of itself (I personally think this is the main reason for Habeo's clinical effectiveness in diffuse cutaneous scleroderma and not in early stages of the illness).

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JP Morgan Conference 1/9 08 Jan 2018 13:09 #10900

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Very strange! This event has been deleted from the company website!

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JP Morgan Conference 1/9 08 Jan 2018 14:01 #10901

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franshei wrote: Very strange! This event has been deleted from the company website!


Franshei, is that because it has already been completed, or because the Company cancelled? The latter would be extremely bullish iimo, suggesting significant news that is not quite ready for release.

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JP Morgan Conference 1/9 08 Jan 2018 14:12 #10902

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Rodney
CYTX would sually present the company on the last day of the conference, ie 1/10. The latest day for the PR would be today. This fee for this presentation is almost $ 6000,00.
This event might have cancelled for some important reason.

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JP Morgan Conference 1/9 08 Jan 2018 15:17 #10906

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franshei wrote: Rodney
CYTX would sually present the company on the last day of the conference, ie 1/10. The latest day for the PR would be today. This fee for this presentation is almost $ 6000,00.
This event might have cancelled for some important reason.

On the other hand- the SF conference (was it really JPM or some small other conference?) was never announced in a PR- actually I was waiting for one and since it never came, tuned out on it. Any FDA news - good or bad - is what I am waiting for.

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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:

JP Morgan Conference 1/9 10 Jan 2018 14:55 #10947

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Rodney
KOOL is one of a few cell therapy companies presenting in the J P Morgan Biotech SAhowcase - It has been a big disaster for KOOL! Stock is dropping sharply, as they are closing down the peripheral/limb ischemia study (ASTM did the same during early phase 3 trials).
BoyALife should not have bought KOOL. CYTX is a better choice.
I take another look at KOOL's new corporate strategy - my conclusion is KOOL has to climb the Rockies to win big, while CYTX's path is much, much better and easier-just the Cascades.

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JP Morgan Conference 1/9 10 Jan 2018 15:07 #10948

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franshei wrote: Rodney
KOOL is one of a few cell therapy companies presenting in the J P Morgan Biotech SAhowcase - It has been a big disaster for KOOL! Stock is dropping sharply, as they are closing down the peripheral/limb study (ASTM did the same during early phase 3 trials).
BoyALife should not have bought KOOL. CYTX is a better choice.


Franshei, your last sentence - totally agree without question, but CYTX would not have sold then.

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JP Morgan Conference 1/9 10 Jan 2018 15:18 #10949

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Rodney
This is how you can test Tiago Girao, just like what I have done with the FDA. You can put out your models in different ways for Girao to agree or disagree. Likewise, Wall Street analysts have their own models for the companies to beat the expectation.

I think CYTX has been looking for a Merge and Acquisition opportunity beyond playing solo. But, somehow I think CYTX is very picky to choose the right one. I think the $10 M RO is just buying time = playing with the basics (or what they have for now) and looking around for other options.
BoyALife has really made a major mistake with KOOL.

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JP Morgan Conference 1/9 10 Jan 2018 15:33 #10950

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franshei wrote: Rodney
This is how you can test Tiago Girao, just like what I have done with the FDA. You can put out your models in different ways for Girao to agree or disagree. Likewise, Wall Street analysts have their own models for the companies to beat the expectation.

I think CYTX has been looking for a Merge and Acquisition opportunity beyond playing solo. But, somehow I think CYTX is very picky to choose the right one. I think the $10 M RO is just buying time = playing with the basics (or what they have for now) and looking around for other options.
BoyALife has really made a major mistake with KOOL.


Franshei, Tiago will no longer respond to me after we had some confrontations - so be it!.

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JP Morgan Conference 1/9 10 Jan 2018 15:37 #10951

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NVAX touting they can salvage their RSV vaccine at JPM and stock popped nicely, why did CYTX cancel their STAR update again ?
Houston, we have a problem...post more job listings !!! LOL :evil: Houston job listings.

They popped CYTX and then selling it ? That is your question...WHY ?

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