Welcome, Guest
Username: Password: Remember me
April 13 2016 is the date of the public hearing, which is of extreme importance for the future of Cytori as a Company. It will likely also determine whether Cytori is "partnerable" or not.
  • Page:
  • 1

TOPIC: Real World Evidence to be allowed

Real World Evidence to be allowed 09 Dec 2018 12:37 #12386

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3357
  • Thank you received: 1116
Just as a side note, but might become relevant if going concern issues are cleared...

New decision by FDA to allow RWE and RW data in the approval process for drugs and therapies - I mean- which company besides Cytori have clinics done on their behalves because of scientific interest all over the globe?

The US Food and Drug Administration (FDA) on Thursday unveiled a new framework discussing how the agency will use real world evidence (RWE) and real-world data (RWD) to help companies win new indications for approved drugs and biologics, expand labels or satisfy post-approval study requirements.

As far as what the framework will guide FDA on specifically, the agency said its RWE program will evaluate the potential use of RWE to support changes to labeling about drug product effectiveness, including adding or modifying an indication, such as a change in dose, dose regimen or route of administration; new populations; or the addition of comparative effectiveness or safety information.

“The RWE framework will also consider the evaluation of observational clinical studies using RWD to support product effectiveness determinations,” FDA said.


link to full FDA article - HERE

Please Log in or Create an account to join the conversation.

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:

Real World Evidence to be allowed 09 Dec 2018 18:22 #12387

  • rongside
  • rongside's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 388
  • Thank you received: 196
I fear too little, too late.

Please Log in or Create an account to join the conversation.

Real World Evidence to be allowed 10 Dec 2018 04:59 #12388

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3357
  • Thank you received: 1116
We will know soon.

Somehow I cannot believe that financing a couple of Mio or refinancing the Oxford loan can be so difficult with all the unvalued intangible assets that Cytori possesses, but than again- you might be right. :whistle:

Please Log in or Create an account to join the conversation.

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:

Real World Evidence to be allowed 10 Dec 2018 09:16 #12389

  • rodney.strongg
  • rodney.strongg's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 1362
  • Thank you received: 19

fas wrote: We will know soon.

Somehow I cannot believe that financing a couple of Mio or refinancing the Oxford loan can be so difficult with all the unvalued intangible assets that Cytori possesses, but than again- you might be right. :whistle:


I tend to agree with you, but the stock is certainly not acting as if there is anything in the works, and time is running out.

Please Log in or Create an account to join the conversation.

Real World Evidence to be allowed 10 Dec 2018 11:37 #12390

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3357
  • Thank you received: 1116
You always seem to assume that the stock market know more than we do. I personally do not think that is correct.

Please Log in or Create an account to join the conversation.

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:

Real World Evidence to be allowed 10 Dec 2018 12:29 #12391

  • rodney.strongg
  • rodney.strongg's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 1362
  • Thank you received: 19

fas wrote: You always seem to assume that the stock market know more than we do. I personally do not think that is correct.

/

Not sure how you can make that statement - based upon the ton of money that you, myself and many others on this site have lost on CYTX over the years, I would say that the stock market so far has won by an enormous margin.

Please Log in or Create an account to join the conversation.

Real World Evidence to be allowed 10 Dec 2018 12:51 #12392

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3357
  • Thank you received: 1116
If the definition of stock market is being short- than you are right. However I do not think that is the standard definition.

Please Log in or Create an account to join the conversation.

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:

Real World Evidence to be allowed 10 Dec 2018 13:47 #12393

  • rodney.strongg
  • rodney.strongg's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 1362
  • Thank you received: 19

fas wrote: If the definition of stock market is being short- than you are right. However I do not think that is the standard definition.

/

My point is that all the many times over many years that we bought CYTX when the stock market had a CYTX price that we perceived was a great buy, always turned out to be wrong as the price always continued to eventually deteriorate further over time - so we the buyers were wrong and those that were right were not just the shorts but also those that sold their holdings (i.e., the stock market in general)./

PS - Of course, we can only hope that this time will be different - hope springs eternal.

Please Log in or Create an account to join the conversation.

Real World Evidence to be allowed 11 Dec 2018 12:42 #12394

  • b767cpt
  • b767cpt's Avatar
  • Offline
  • Gold Boarder
  • Gold Boarder
  • Posts: 303
  • Thank you received: 4
You guys sound like you’re getting close to throwing in the towel.

Whoever has been manipulating this stock is close to achieving their goal of picking it up for pennies on the dollar at our expense.

Please Log in or Create an account to join the conversation.

Real World Evidence to be allowed 11 Dec 2018 14:01 #12395

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3357
  • Thank you received: 1116
B7 - like I have mentioned before I am not throwing in the towel before the "end" is clear. Would be stupid, in my view- a few hundred $ invested now could grow quickly if they manage to survive until say mid 2020. And I have positioned myself accordingly without breaking the bank. At my age and in my situation, money does not rule my life any longer anyway.

We should know in 3-4 weeks- defaulting on the Oxford loan obviously is a material event, which requires immediate reporting at the first trading day in 2019. We will see.
The following user(s) said Thank You: b767cpt

Please Log in or Create an account to join the conversation.

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:

Real World Evidence to be allowed 11 Dec 2018 14:14 #12396

  • b767cpt
  • b767cpt's Avatar
  • Offline
  • Gold Boarder
  • Gold Boarder
  • Posts: 303
  • Thank you received: 4
I’m also keeping a watchful eye Fas, partnership or Oxford restructuring and I also will ante up some more. Those jumping in at the right time could have riches ahead.

Please Log in or Create an account to join the conversation.

  • Page:
  • 1
Time to create page: 0.093 seconds

Copyright Information

Copyright Fas Kuiters © 2016 young-foxes.com. All Rights Reserved.
This page is made with Joomla CMS and its various templates designed by Fas Kuiters with the excellent Themler tool.

 

 

Shared Spreadsheet Links

DOV´s Revised Projections for the Periods 2017 until 2020

Shareble link : HERE

Fas Kuiters Websites