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

TOPIC: ATI-1123

ATI-1123 01 Jul 2019 08:10 #12971

  • rodney.strongg
  • rodney.strongg's Avatar Topic Author
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 1278
  • Thank you received: 18
See release this morning re favorable feedback from FDA to proceed with ATI-1123 trials.

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

ATI-1123 01 Jul 2019 09:08 #12972

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2765
  • Thank you received: 199
LOL...too bad algo's don't read balance sheets !!
:grin: :evil: :grin: :evil: :grin: :evil: :really: :really: :really: :bang:

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

ATI-1123 01 Jul 2019 09:23 #12973

  • rodney.strongg
  • rodney.strongg's Avatar Topic Author
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 1278
  • Thank you received: 18

myownhedgefund wrote: LOL...too bad algo's don't read balance sheets !!
:grin: :evil: :grin: :evil: :grin: :evil: :really: :really: :really: :bang:

//

Stock currently up 38% at .33 on 4 million shares (10:22 am).:/
PS - back down to .27 at 11:50am./

PS - 7/3 - stock back down to .24 - total BS!!!

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

ATI-1123 01 Jul 2019 10:23 #12974

  • fas
  • fas's Avatar
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3298
  • Thank you received: 1110
here is the text of the message

Jul 01, 2019
AUSTIN, Texas, July 01, 2019 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ: CYTX) today provided an update on the development of its proprietary drug, ATI-1123, based on recently obtained feedback from the United States Food and Drug Administration (FDA). ATI-1123 is a substantially redesigned and reformulated new drug based in part, on the active pharmaceutical ingredient, docetaxel. ATI-1123 may have future clinical utility in a number of difficult to treat cancers.
The purpose of the Company’s submission was to clarify certain key aspects of the future development plan including: (1) the suitability of the 505(b)(2) pathway for approval of the proposed ATI-1123 drug product, including the proposed listed drug (LD), (2) the adequacy of the referenced clinical, nonclinical and pharmaceutical quality information, in combination with the proposed drug development program, to support the new drug application and (3) any concerns that the FDA may have with regard to other filing issues specific to the product.
Key feedback from the FDA included that a 505(b)(2) application appears to be an acceptable regulatory approach with docetaxel injection as a potentially acceptable LD. Furthermore, the FDA agreed that the completed nonclinical studies are sufficient to support the initiation of the clinical trial of ATI-1123 in patients with platinum-sensitive small cell lung cancer who have progressed at least 60 days after initiation of first-line therapy.
“Small cell lung cancer is an aggressive neuroendocrine malignancy characterized by high metastatic potential and poor relative outcomes,” said Dr. Marc H. Hedrick, M.D. “Due to the propensity of small cell lung cancer to metastasize widely and early in the disease course, it is considered the most lethal lung cancer subtype and new therapies such as ATI-1123, are desperately needed for these patients.”
ATI-1123 has completed a phase I trial. Based on the FDA feedback, the Company plans to proceed with a follow-on phase II trial in platinum-sensitive small cell lung cancer who have progressed at least 60 days after initiation of first-line chemotherapy.


Anyway- seems like they are getting along fine with the FDA. However that was also the case in the Cell Therapy days and heaps of money went in to complying with regulations which changed every year. Now the regulations are clear, but the legislation against the 2 most prominent "Wild wild west" chains are likely to take years and now the FDA started an "education campaign" to explain the rules, although those folks know damn well what the rules are- they simply prefer to ignore them.

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:

ATI-1123 02 Jul 2019 09:05 #12975

  • b767cpt
  • b767cpt's Avatar
  • Offline
  • Gold Boarder
  • Gold Boarder
  • Posts: 279
  • Thank you received: 4
Hate to be cynical but this fluff is becoming like clockwork, being released just prior to them pumping for something they want.

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

ATI-1123 02 Jul 2019 09:45 #12976

  • fas
  • fas's Avatar
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3298
  • Thank you received: 1110
B7- they have 17 years experience with announcements that brings something- i.e. money or FDA approvals and what does not bring something besides an occasional volume spike i.e. all the rest. Bet they sold some shares to increase the petty cash, but that is all.

All they want at present is their 50% vote on proposal 4 of the ASM, but there they can rely solely on record holders from way back when in April or something and I bet > 60% of shareholders at that time are no holders any longer at this point in time.
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:

ATI-1123 02 Jul 2019 10:05 #12977

  • b767cpt
  • b767cpt's Avatar
  • Offline
  • Gold Boarder
  • Gold Boarder
  • Posts: 279
  • Thank you received: 4
I’ve lost all hope of recouping what I unfortunately have in this Fas, even if the ATI-1123 takes off like a rocket launch. RS have destroyed any chance for long term holders to recover. New people coming in may benefit from it.
I still haven’t converted what little I put into that last RO and now wonder how that will be affected from the language in that RO with a new offering.

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

ATI-1123 02 Jul 2019 10:57 #12978

  • fas
  • fas's Avatar
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3298
  • Thank you received: 1110
Yeah- of course I have mentally written off my investments also- thank god I can do that without caring much about it.

I have not converted my C´s either, although I do not expect they will do a RO or public offering. Actually I see them on the OTC in a few months, but than again "no hope no dope" (dope being dopamine- the happy hormone)

Actually it is pretty sad really- on my terrace where I often sit to relax and to enjoy the weather and my gold fish pond, I look straight to the bedroom window of my (female) neighbor. 4-5 years ago she had breast cancer and got the full treatment- radiation, chemo, the works. Now she is dying at, by my estimate 55-60 years old, complete metastasis all over the body, again by my own estimation, due to a complete collapse of the immune system caused by that treatment/junk.

And I am invested in a company that wants to sell that stuff- and by my guess they probably will. Judas money??

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:

ATI-1123 02 Jul 2019 12:46 #12979

  • rodney.strongg
  • rodney.strongg's Avatar Topic Author
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 1278
  • Thank you received: 18

fas wrote: Yeah- of course I have mentally written off my investments also- thank god I can do that without caring much about it.

I have not converted my C´s either, although I do not expect they will do a RO or public offering. Actually I see them on the OTC in a few months, but than again "no hope no dope" (dope being dopamine- the happy hormone)

Actually it is pretty sad really- on my terrace where I often sit to relax and to enjoy the weather and my gold fish pond, I look straight to the bedroom window of my (female) neighbor. 4-5 years ago she had breast cancer and got the full treatment- radiation, chemo, the works. Now she is dying at, by my estimate 55-60 years old, complete metastasis all over the body, again by my own estimation, due to a complete collapse of the immune system caused by that treatment/junk.

And I am invested in a company that wants to sell that stuff- and by my guess they probably will. Judas money??

//
Fas, I understand the point that you are making about the shortfalls in the medical and pharmaceutical industries; however, you do not know if your neighbor might have died within one year w/o the treatments - depends how advanced the breast cancer was at initial detection.

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

ATI-1123 03 Jul 2019 10:25 #12981

  • fas
  • fas's Avatar
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3298
  • Thank you received: 1110
Rodney- I cannot know. But I do have read statistics and they are not good.

25+ years ago, I had a dreadful conversion with the treating doctor of my wife, after they took out a tumor the size of a football from her ovary, which at one time we thought was our third child. I had to prepare for the worst. Thank god my wife refused "the worst", just had some localized radiation and went to an alternative clinic for treatment.
However that meant - she was taken out of the statistics for follow up, since that was NOT the recommended treatment. My wife never had remission, strengthened her immune system and is still alive and kicking- 25+ years later.

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:

ATI-1123 03 Jul 2019 11:33 #12982

  • rodney.strongg
  • rodney.strongg's Avatar Topic Author
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 1278
  • Thank you received: 18

fas wrote: Rodney- I cannot know. But I do have read statistics and they are not good.

25+ years ago, I had a dreadful conversion with the treating doctor of my wife, after they took out a tumor the size of a football from her ovary, which at one time we thought was our third child. I had to prepare for the worst. Thank god my wife refused "the worst", just had some localized radiation and went to an alternative clinic for treatment.
However that meant - she was taken out of the statistics for follow up, since that was NOT the recommended treatment. My wife never had remission, strengthened her immune system and is still alive and kicking- 25+ years later.

/

Fas, what a great outcome - God Bless both of you for getting through that ordeal ---- I am not really a strong advocate of the medical/pharma industries and you certainly could be right on this whole issue!

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

ATI-1123 06 Jul 2019 11:53 #12996

  • SH
  • SH's Avatar
  • Offline
  • Junior Boarder
  • Junior Boarder
  • Posts: 38
  • Thank you received: 6
Fas, glad to hear things worked out well for your wife. I can imagine especially 25 years ago how much doctors only used chemo. Wishing you both best of health. I hope to one day be in as good shape as you. On a different note I think only a vita has a good chance to make it in stem cells. Lots of private companies but it will be few years

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

ATI-1123 08 Jul 2019 11:24 #12998

  • fas
  • fas's Avatar
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3298
  • Thank you received: 1110
Thanks for the good wishes SH. Appreciated. Anyway- health- whilst aging- needs a mind change in nutrition I believe. My wife is 13 years younger than I am and as a former ( a long long time ago) professional cook (worked in fancy restaurants) still has problems given up the things she was taught on nutrition. Its coming - but much slower than I hoped for considering the change she sees in me, compared to the change in herself now going to 60.. Anyway- she still has a few years to see the light.

On the other topic- I am lost on what you mean with "vita" - does not ring a bell with me- can you explain?

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:

ATI-1123 08 Jul 2019 15:09 #12999

  • rodney.strongg
  • rodney.strongg's Avatar Topic Author
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 1278
  • Thank you received: 18

fas wrote: Thanks for the good wishes SH. Appreciated. Anyway- health- whilst aging- needs a mind change in nutrition I believe. My wife is 13 years younger than I am and as a former ( a long long time ago) professional cook (worked in fancy restaurants) still has problems given up the things she was taught on nutrition. Its coming - but much slower than I hoped for considering the change she sees in me, compared to the change in herself now going to 60.. Anyway- she still has a few years to see the light.

On the other topic- I am lost on what you mean with "vita" - does not ring a bell with me- can you explain?

/

He must mean Avita - HF referred to this company last week.

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

ATI-1123 09 Jul 2019 10:48 #13000

  • fas
  • fas's Avatar
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3298
  • Thank you received: 1110
Yes- of course- my fault.
We will see- MesoBlast has been in business as long as I can remember and will be approaching crunch time in the next 1-2 years. I think their cost and the resulting price- tags - if they succeed- will be prohibitive for coverage.

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:
  • Page:
  • 1
Time to create page: 0.114 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