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TOPIC: FDA Meeting again/STAR

FDA Meeting again/STAR 12 Feb 2018 19:59 #11264

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Rodney
Apparently, the feedback from this meeting would drive the future direction for the whole Cell Therapy. Tiago Girao confirms that nothing is definite at this point. The feedback is coming very soon.I think they may have some ideas, but they need the official feedback. FDA can always change their mind from any earlier understanding.
One thing is for sure : Secondary Raynauld's (under Habeo, Pipeline at the company website) has been dropped. This new pipeline scheme may indicate what the management has in mind.
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FDA Meeting again/STAR 13 Feb 2018 00:27 #11266

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Is anyone willing to confirm they have added shares post RO and based on all the speculation of the last couple of weeks ?

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FDA Meeting again/STAR 13 Feb 2018 05:03 #11267

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myownhedgefund wrote: Is anyone willing to confirm they have added shares post RO and based on all the speculation of the last couple of weeks ?


Is anyone willing to confirm they have reduced shares post RO and based on all the speculation of the last couple of weeks?

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FDA Meeting again/STAR 13 Feb 2018 06:01 #11268

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Do the math, folks. Does anyone really believe the cell therapy personnel is disappearing and the Raynaud's pursuits are disappearing because they have anything but negative feedback from the FDA? Common sense, people, common sense. Of course they've received the negative feedback by now, and of course they're once again withholding material information.

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FDA Meeting again/STAR 13 Feb 2018 07:00 #11269

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waddlingwillbologni wrote: Do the math, folks. Does anyone really believe the cell therapy personnel is disappearing and the Raynaud's pursuits are disappearing because they have anything but negative feedback from the FDA? Common sense, people, common sense. Of course they've received the negative feedback by now, and of course they're once again withholding material information.


That would mean Tiago is lying to Franshei??

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FDA Meeting again/STAR 13 Feb 2018 07:25 #11270

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Wadd
Perhaps you missed where I calculated that a large part of the cell business is sold for $0.06 a share (fully diluted.) based on franshei's speculations with KOOL. WooHoo....LOL

RS
***Is anyone willing to confirm they have reduced shares post RO and based on all the speculation of the last couple of weeks? ***
Yes, we have 2 filings now stating so !!!

***That would mean Tiago is lying to Franshei??***
Lying ? He hasnt said ANYTHING.

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FDA Meeting again/STAR 13 Feb 2018 07:38 #11271

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myownhedgefund wrote: Wadd
Perhaps you missed where I calculated that a large part of the cell business is sold for $0.06 a share (fully diluted.) based on franshei's speculations with KOOL. WooHoo....LOL

RS
***Is anyone willing to confirm they have reduced shares post RO and based on all the speculation of the last couple of weeks? ***
Yes, we have 2 filings now stating so !!!

***That would mean Tiago is lying to Franshei??***
Lying ? He hasnt said ANYTHING.


Paragraph 1 - your calculations, not Franshei!

Paragraph 2 - we all know about the two filings selling modest portions of total holdings - we all assumed that you were talking about Board Members - if not, we have two filings establishing approx. 12% stakes each even after minor sales!

Paragraph 3 - one of Franshei's posts indicated that Tiago told him that CYTX had not yet been informed by the FDA.

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FDA Meeting again/STAR 13 Feb 2018 09:19 #11275

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1. I'm sorry, the 10 times a $5 million example was offered was in my imagination. LOL
2. ***we all*** ? DOUBLE LOL
3. He hasnt said ANYTHING.

$5/share here we come !!!!!
Because Maxim has such a firm handle on valuation. I mean why else sell at $0.3333 with free warrants ?

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FDA Meeting again/STAR 13 Feb 2018 09:30 #11276

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myownhedgefund wrote: 1. I'm sorry, the 10 times a $5 million example was offered was in my imagination. LOL
2. ***we all*** ? DOUBLE LOL
3. He hasnt said ANYTHING.

$5/share here we come !!!!!
Because Maxim has such a firm handle on valuation. I mean why else sell at $0.3333 with free warrants ?


You really are a piece of work!

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FDA Meeting again/STAR 13 Feb 2018 10:27 #11283

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Rodney
The Pipeline page on the company website is probably an outline of the current activities.
My current understanding is as follow:
1. Company has retained a critical mass to go forward in both cell therapy and nanomed. Corporate development in relationship to restructuring is ongoing as highlighted in the September PR.
2. STAR data is being presented in a French Medical Meeting this week (under Events on company website).
3. FDA official letter re STAR presubmission is coming very soon. This is a very important event for the scleroderma project. My personal opinion is the company knows what is coming, but they have to wait for the official letter. As in any court/legal decision, a delay decision is always a carefully considered decision. Usually, a negative decision comes very fast (as in a very recent case with VCEL).
You should always communicate with Tiago Girao directly for information.
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FDA Meeting again/STAR 13 Feb 2018 11:13 #11284

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Rodney
This is purely my own guessing:
The Secondary Raynauld's became a therapeutic target was purely based on early observations in the Scleradec I trial, mostly in more advanced sickness, in which the early signs of healing included improvement in the Raynauld's. However in the broadened US STAR study including early stages of the sickness, this kind of Raynauld's healing is not evident. For further development for the scleraderma indication in the US, there is no basis to pursue Secondary Raynauld's.
I think CYTX is asking the FDA to allow a very narrow/limited approval for diffuse cutaneous scleroderma, as Habeo is safe and clinically effective. With this narrow approval (PMA has yet to be filed, if the permission is allowed), CYTX can go to the next stage for use in combination with CYTOXAN (experimental for scleroderma) in a phase 4 setting. This is where Habeo has its rightful place in treating scleroderma and this is where the medical community wants. If the limited approval is not granted, the combination trial leading to final PMA approval cannot be started -FDA would not allow two experimental drugs to be used at the same time for approval purposes.
For such a combination trial, I believe CYTX has to work with a partner. If the FDA's decision would lead to such a combination route, I think a real pharma/biotech partner would probably come forward - it is now "real" drug development.

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FDA Meeting again/STAR 13 Feb 2018 11:18 #11285

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franshei wrote: Rodney
Apparently, the feedback from this meeting would drive the future direction for the whole Cell Therapy. Tiago Girao confirms that nothing is definite at this point. The feedback is coming very soon.I think they may have some ideas, but they need the official feedback. FDA can always change their mind from any earlier understanding.
One thing is for sure : Secondary Raynauld's (under Habeo, Pipeline at the company website) has been dropped. This new pipeline scheme may indicate what the management has in mind.


I don’t see how Tiago could “confirm” anything until they get the official letter from the FDA. He would have to do a tap dance around any direct question which would disclose potential insider information prior to its release. In other words, I wouldn’t expect a straight up answer from him on anything.

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FDA Meeting again/STAR 13 Feb 2018 12:20 #11286

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I just don't see much benefit for long term share holders in any of these FDA speculations franshei
1. If they can file a PMA it will be some time to do so and then they will again need cash to keep the lights on let alone run the phase 4

2. If they go the partnership route they will get some $ upfront but a small piece of the pie of a small market in the form of royalties. It solves little long term and again they will still have to raise funds to keep the lights on. This assumes that they even get to market and more than a handful of sales materialize. Circa 2020 ? Later ?

3. If its a outright sale of the cell business...its worth little at this point. It wont be much but perhaps they get to push out a next raise by a few months. Maybe.

The last few days in considering of what you have proposed...I only see scenario #2 MORE OF THE SAME and we were on track before all of this discussing a R/S and more DILUTION !!! That's why the PPS lingers and drifts. We may see some small swings if one of these events happen but in the end, MORE OF THE SAME.

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