Welcome, Guest
Username: Password: Remember me
General
  • Page:
  • 1

TOPIC: BARDA Agreement Officially DEAD

BARDA Agreement Officially DEAD 23 Jul 2019 08:15 #13059

  • Wall Street Titan
  • Wall Street Titan's Avatar Topic Author
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 902
  • Thank you received: 148
The final nail in the coffin of Cytori Therapeutics and autologous adipose derived stem cell treatments...

On July 21, 2019, Cytori Therapeutics, Inc. (the “Company”) received an order from the U.S. Department of Health and Human Services / Office of the Assistant Secretary for Preparedness and Response / Biomedical Advanced Research and Development Authority (“HHS/ASPR/BARDA”) regarding Contract HHSO100201200008C dated September 27, 2012 (as amended, the “Agreement”) to suspend all work on the referenced contract, including the RELIEF clinical trial, except for certain activities related to orderly close out of the trial and contract. This order was based on previous discussions between the Company and HHS/ASPR/BARDA concerning the best path forward for both parties in the light of the difficulty of enrolling the RELIEF trial and the Company’s previously disclosed restructuring plan. Pursuant to the order, within a period no longer than 180 days (or by January 17, 2020), the contract will be terminated by HHS/ASPR/BARDA.

Yet no ramifications to the CEO who oversaw this collapse.

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

BARDA Agreement Officially DEAD 23 Jul 2019 10:31 #13060

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2865
  • Thank you received: 204
No surprise here....at least we stop wasting U S taxpayer money in terms of SOC burn treatment, even w/o Avita, it was a pie in the sky dream imho.
We recently heard back from franshei....maybe DOV will pop in for comment as his lofty burn revenue projections are now officially dead. Although I did warn him use in that space was going to be quite limited at best.
Couldnt even enroll 1 patient it seems.

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

BARDA Agreement Officially DEAD 23 Jul 2019 15:17 #13061

  • rodney.strongg
  • rodney.strongg's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 1363
  • Thank you received: 19

myownhedgefund wrote: No surprise here....at least we stop wasting U S taxpayer money in terms of SOC burn treatment, even w/o Avita, it was a pie in the sky dream imho.
We recently heard back from franshei....maybe DOV will pop in for comment as his lofty burn revenue projections are now officially dead. Although I did warn him use in that space was going to be quite limited at best.
Couldnt even enroll 1 patient it seems.

/

Not sure that I agree with your read - BARDA was a great opportunity for the fledgling CYTX at the time it was received - somehow they managed to screw it up along with the rest of their stem-cell business.

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

BARDA Agreement Officially DEAD 23 Jul 2019 15:41 #13062

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2865
  • Thank you received: 204
Somehow ????????
LOLOLOLOL !!!!!!!!!!!!!!!!!

Look the nuclear prep thing was one thing and the government continues on with various deployments...namely most recently, radiation monitoring sensors in cities. This after years of monitoring natural background radiation.
What Cytori tried to do with the burn market in general was flawed on so many levels and BARDA changes werent to blame....they were to correct poor foresight by Cytori starting with the lipo route. Anyway...easy to find years of complaints from me on this former app. Others differed which was fine. End result is another failure by the company.
Curious when we hear from them in August.

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

BARDA Agreement Officially DEAD 23 Jul 2019 18:19 #13063

  • rongside
  • rongside's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 388
  • Thank you received: 196
We finally learn about the status of BARDA trials.
Last nail in the coffin of Cytori's regenerative medicine adventure.
A case study in missed opportunities due to incompetence, megalomania, litigation delays (FDA) etc.
Management and the BoD were incompetent, if not corrupt. They were abetted by suspect Wall Street financings and manipulations.

It was not due to ADRC not working, nor that they were autologous. ADRC work.
Consider if they had not gone into the cancer space and had instead concentrated on a diffuse scleroderma confirmatory trial. We would probably/possibly have had and approved drug by now.

No surprise that the government ceased to fund Cytori. Question is whetherBARDA will be prepared to finance someone else, (and who) ?
Who gets the benefit? Lorem Vascular, or possibly some other end acquirer of EVERYTHING WE PAID FOR.

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

BARDA Agreement Officially DEAD 24 Jul 2019 14:01 #13064

  • Wall Street Titan
  • Wall Street Titan's Avatar Topic Author
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 902
  • Thank you received: 148

It was not due to ADRC not working, nor that they were autologous. ADRC work.


I have to differ with this statement. Their trial FAILED in knee osteoarthritis. Don't want to hear that placebo arm outperformed. The autologous model was the main culprit and the need for a lipo on every patient. The logic of using off-the-shelf stem cells from healthy young donors that are disease free is just too overwhelming. Yes, there is the expandability problem but a couple of companies like Athersys and Cynata don't have an issue with scalability. Both Tigenix and Capricor realized this and abandoned the autologous route. Avita Medical is the exception to autologous failure because taking a very small and thin layer of skin is non invasive and the technology fits very well within wound healing procedures as they already exist. In retrospect, Cytori was probably doomed from the outset. Even if they had found early clinical success, their lead would have eventually been overtaken by allogeneic, IMHO. Now the wait is on the see if allogeneic actually succeeds in the clinic.

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

BARDA Agreement Officially DEAD 24 Jul 2019 19:03 #13065

  • rongside
  • rongside's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 388
  • Thank you received: 196
It was poor management that let CYTX and autologous ADRC down.

All the allogeneic companies you referenced are still a long way from approval, except Takeda/Tigenix.

In the case of Alofisel/Tigenix IMO the method of action of autologous ADRC is similar. There is trial data that strongly validates the use of autologous ADRC via the Celution system in effectively treating fistula wounds (Crohns).

As per the attached link the cost of the great allogeniec treatment paradigm is such that todate it has been a financial failure. The cost of treating fistula with Celution would have been SUBSTANTIALLY cheaper and in my opinion as effective, if not more so.

The failure is not in the autologous model. It is poor management, and a desire from the powers that be that all drugs/therapies have a high level of complexity so that they can be easily defended in the market place, .......... not the hospital.

I believe that one day we will see our ''old'' technology, rewrapped, remarketed, repositioned, refocused and primed for success. I just want to know to whom Cytori gave away the future ............my only caveat is whether regulators are prepared to allow such an effective treatment paradigm which is easily replicable into the market given the already documented possibility of massive abuse.

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

BARDA Agreement Officially DEAD 24 Jul 2019 19:10 #13066

  • rongside
  • rongside's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 388
  • Thank you received: 196
''As per the attached link the cost of the great allogeniec treatment paradigm is such that todate it has been a financial failure. The cost of treating fistula with Celution would have been SUBSTANTIALLY cheaper and in my opinion as effective, if not more so.''

Here is the link I reffered to:

www.pharmaceutical-technology.com/comment/crohns-disease-drug/

I would love to see a comparative trial between Aloficel and Celution/ADRC. Probably never going to happen for obvious reasons, one of which is they will never be able to fill the allogeneic Aloficel arm...LOL.

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

BARDA Agreement Officially DEAD 25 Jul 2019 16:08 #13068

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2865
  • Thank you received: 204
I guess we could discuss the meaning failure in trial vs management.
Management always tried to spin these failures in one way or another.
The last was scleroderma and they were going to tease out the true data in France....crickets followed...why ?

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

BARDA Agreement Officially DEAD 25 Jul 2019 17:58 #13069

  • rongside
  • rongside's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 388
  • Thank you received: 196
Good question. I suppose after having given up on ADRC/Celution technology or having bedded it down somewhere else, it is highly unlikely that the would actively try to expedite the results and inform their shareholders ......... particularly after having divested it. I will keep my ears to the ground and will be looking out for the results of the french scleroderma trial, even if only out of academic curiosity.

Crazy isn't it but the divested Puregraft is probably worth much more than CYTX. I wonder who gets the royalty payments now?????:KO:

www.puregraft.com/

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

BARDA Agreement Officially DEAD 25 Jul 2019 20:49 #13070

  • rongside
  • rongside's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 388
  • Thank you received: 196
Actually, I think it is worthwhile to also review the progress of the fistula trials being underaken in Marseille. We know that the initial trial underaken was positive and it appears that the french wish to take on a bigger trial (see below). How his will be undertaken given Cytori's disinvestment is an issue. Perhaps Lorem vascular will continue to support IIS (independent investigator studies)?

Double blind, placebo trial. Shouldn't be a problem recruiting given that Alofisel/TiGenix/Takeda not on the market
Sheer number of trials being undertaken using ADRC is of interest.

www.smartpatients.com/trials/NCT04010526

Previous trial data:
www.ncbi.nlm.nih.gov/pubmed/29321063

www.ecco-ibd.eu/publications/congress-abstract-s/abstracts-2017/item/op008-an-innovative-treatment-for-refractory-perianal-fistulas-in-crohn-s-disease-local-micro-reinjection-of-autologous-fat-and-adipose-derived-stromal-vascular-fraction.html

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

  • Page:
  • 1
Time to create page: 0.098 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