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TOPIC: Schleroderma phase 3 pivotal multicenter trials

Schleroderma phase 3 pivotal multicenter trials 09 Jul 2015 08:11 #4806

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The study initiation should come midyear. DOV comments that there is a lot of paper work for the trials and it takes time.

Very true. On top of the usual FDA approved documents (protocol, clinical brochure, 1573, etc.), they need the case report forms, patient consent forms, IRB approvals.... There is always modification alone the way and very often FDA is involved. Things would be complicated when 1. there are 20 study sites; 2. study monitoring by in house CRAs (to cut cost, instead of using a CRO); 3. lack of digital case report forms (in all or some study sites);4. budget negotiation (study contracts) with the PRs, etc. Usually there Is a need to have an investigators' meeting to go over all the details, in order to do things right.

I hope we would hear something on this initiation this month, before the annual stockholders' meeting or the next earning release.

In the case of the OA study, Rush is always a great site, because there is an in house "CRO" setup.

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Schleroderma phase 3 pivotal multicenter trials 09 Jul 2015 09:30 #4807

  • myownhedgefund
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So what are you saying franshei....a delay the projected scleroderma trial start ?

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Schleroderma phase 3 pivotal multicenter trials 20 Jul 2015 08:53 #4844

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Mr Hedge, I think the phase 3 schleroderma multi center trials have already started. This is only my speculation.

Then, why no PR?

I think the news will come during the next earning CC, but not before (very different from last year this time, when there was a lot of good news before the 2nd Q earning call to cover pending bad news).

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Schleroderma phase 3 pivotal multicenter trials 20 Jul 2015 10:48 #4846

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Yes, scleroderma was supposed to be started by now...I think they have but have no confirmation.
Hedrick needs something to talk about on the CC....it wont be the sales numbers.
Will it be our mystery app on funds to run a new trial ?
With OA enrolled it will be how fast we can enroll scleroderma that will interest me.

I thought your post i responded to on this thread sounded like you thought a delay was possible....just seeking clarification on your thoughts on the matter.

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Schleroderma phase 3 pivotal multicenter trials 24 Jul 2015 08:10 #4858

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I thought the French Schleradec-II trial was to start this summer. The Star trial by Cytori in the USA is supposed to start this fall. That seems likely to me since they expanded the trial sites to 20 from 12.

Cytori is out of press release ammo with the exception of first patient enrolled announcements until Feb/Mar time frame when ACT-OA results will be ready. This excludes quarterly CC discussions, of course.

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Schleroderma phase 3 pivotal multicenter trials 24 Jul 2015 08:38 #4859

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Hmmmm...I thought star was supposed to be this summer....but I could be wrong.

No wonder we are at $0.44 LOL :evil:

Doesnt matter I guess...there are real companies out there moving worth more of my attention right now. :winky:

I am sure the ASM will be a real fun. :puke:

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Schleroderma phase 3 pivotal multicenter trials 24 Jul 2015 09:00 #4860

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This company makes me sick to my stomach. In fact, I hate logging into my etrade account knowing what will greet me each morning. Is it bad that I prefer to not even glance in the direction of the screen that shows my profit/less column?

I sent Hedrick a note early this week asking when the plan for overly communicating would kick in - since that was promised to us many, many months ago. I did it in a cordial, information gathering tone. No response of course.

On the brighter side the entire stem cell sector has been completely pounded the past several months. I do think manipulators want to cripple these types of companies so bad that they can never recover only to either be gobbled up for nothing or to never be a disruption to pharma in the US. Sadly, all of us long-term holders only can pray that Hedrick and company have our best interest. From past to present, I don't think they do - what would make them change into the future? How about a new CEO? Hopefully DOV or someone with fairly regular cadence with mgmt can help keep my faith while we sink to our 52 week low.

Worst investment ever so far... ugh.

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Schleroderma phase 3 pivotal multicenter trials 24 Jul 2015 09:28 #4861

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The time for action was long ago when there was still a company with a market cap that a REAL CEO could do something with.

The BOD failed (as most do)

There is nothing Hedrick can do....the devils were let in long ago. :evil:

As we wait for data what really needs to be considered is " if " a reverse split is forced upon them that they do it at a proper ratio so that they are not forced right below a dollar again. :cry:

You may have missed DOV's comment. Hedrick cant afford to buy more CYTX shares....LOL
Maybe he is gearing up to push for a BIG raise. :joy:

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Schleroderma phase 3 pivotal multicenter trials 24 Jul 2015 09:36 #4862

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This company makes me sick to my stomach. In fact, I hate logging into my etrade account knowing what will greet me each morning. Is it bad that I prefer to not even glance in the direction of the screen that shows my profit/less column?


5874,

Kind of like chinese water torture isn't it. When you think it can't get worse it does. Blaming big pharma is a ruse. The air is out of the room.

At least you were brave enough to bring up the name Cytori. Don't see much of it on this site any more. Maybe we are trying not to "glance"!

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Schleroderma phase 3 pivotal multicenter trials 24 Jul 2015 09:43 #4863

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Hedge, I missed the comment about Hedrick not being able to buy more shares. Not sure if that's a joke or something serious.

What would even indicate he would be wanting to buy more shares anyway? These clowns never put much of their own personal wealth in the game. I know there were a few purchases by Rickey and Girao in late 2014, but there has not been one purchase in 2015 (if i recall).

How you can pay a leader this much money is beyond me for such a cash strapped, penalty-boxed company. Disgusting. And yes, we've all cried out about this many months and years ago.

www.bloomberg.com/research/stocks/people/person.asp?personId=1276496&ticker=CYTX

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Schleroderma phase 3 pivotal multicenter trials 24 Jul 2015 11:00 #4864

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**** Not sure if that's a joke or something serious.*****

Sadly, not a joke.
Kids in college you know.
...or so we hear.

Insider buys really never mattered anyway...they were always rather small and they just as quickly put their own money to sleep as they did our own. Exception: CC who had no qualms cashing out when ever possible !!!!

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Schleroderma phase 3 pivotal multicenter trials 24 Jul 2015 21:18 #4865

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Nice! Never saw that posted or had heard that comment.

While his children go to college (on his $1M+ annual comp package), one share of common stock that was going to be used for my children's college tuition (years down the road) is now worth less than a jumbo, sparkly bouncy ball that comes out of a dual 25 cent slot vending machine.

The prairie is full of wolves right now, perhaps, just perhaps, we get a few grizzlies to come in and clear a path to the other side of the mountain for us.

Time will tell.

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Schleroderma phase 3 pivotal multicenter trials 26 Jul 2015 08:01 #4870

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myownhedgefund wrote: As we wait for data what really needs to be considered is " if " a reverse split is forced upon them that they do it at a proper ratio so that they are not forced right below a dollar again. :cry:


Do I understand correctly that your assumption is that they will most likely have to do a R/S? Just asking as I understood in the past your view was that Cytori would not have to do a R/S as they can/could wait for OA and Scleroderma data... if those will be good, no need for R/S, if data is bad they can close the shop...
Really hard to judge... if they really do a R/S it might make sense to sell now even with a substantial loss as the value will go down (empirical evidence in general in case of a R/S) and buy back later (i.e. lower)... on the other hand at some point market cap needs to matter... let's say they do a 5:1 split, then a price below 1 USD would mean sth. like a market cap of around USD 30m.... :KO:

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Schleroderma phase 3 pivotal multicenter trials 27 Jul 2015 10:17 #4874

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laguno

Notice "if" was placed in quotations and done intensionally. It can be a powerful little word.
I dont know if they do a reverse split or not. I dont know if they get a extension before they have to make a decision.
All I was saying is I hope they are smart about it should such a event occur.

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Schleroderma phase 3 pivotal multicenter trials 27 Jul 2015 11:22 #4876

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mr5874 wrote: I sent Hedrick a note early this week asking when the plan for overly communicating would kick in


I suppose you mean overt communication...

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Schleroderma phase 3 pivotal multicenter trials 27 Jul 2015 14:54 #4878

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myownhedgefund wrote: laguno

Notice "if" was placed in quotations and done intensionally. It can be a powerful little word.
I dont know if they do a reverse split or not. I dont know if they get a extension before they have to make a decision.
All I was saying is I hope they are smart about it should such a event occur.


Sure, I posted my message to you based on the quotations... My understanding was actually that you wanted to indicate by them that the "if" is not a real "if" for you anymore but rather your most likey scenario. Nobody of us knows, that's quite obvious, LOL :grin:
But I think this board is also about discussing scenarions (and apparently sometimes subtleties of language) :winky:

You are a reasonable guy and I value your opinion, that's why I was curious :bye:

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Schleroderma phase 3 pivotal multicenter trials 27 Jul 2015 15:28 #4879

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But I think this board is also about discussing scenarios


Well the scenario that I see playing out is that this company will certainly do a reverse split. They will certainly erode the equity of the current investors. They will certainly try to raise more cash by repeating the dilutionary pathways they have in the past. They will do anything in their power to keep their enterprise afloat. It is not about the shareholders. They are merely a funding mechanism.

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