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TOPIC: Update on ATI-0918

Update on ATI-0918 30 Apr 2018 07:44 #11720

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Apr 30, 2018
SAN DIEGO, April 30, 2018 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (Nasdaq:CYTX) (“Cytori” or “the Company”) today provided an update on its plans for US manufacturing and EU approval for its ATI-0918 liposomal doxorubicin product. ATI-0918 has been designed and developed to be bioequivalent to the market leading branded reference drug, Caelyx/Doxil (Johnson & Johnson).

Liposomal doxorubicin is a commonly used cytotoxic agent for recurrent breast and ovarian cancer, multiple myeloma and Kaposi’s sarcoma. The global market is anticipated to grow to $1.4B by 2024 (Grand View Research, Inc., 28 2nd Street, Suite 3036, San Francisco, CA, 94105, United States).

Cytori intends to first seek European approval for its drug and has applied for and has received EMA approval to file for centralized European Union (EU) approval. Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body. Approval by EMA using a centralized procedure leads to approval of the product in all 28 EU Member States, Iceland, Liechtenstein and Norway.

All states of manufacturing of the product will be performed in the United States. More specifically, manufacturing of the cytotoxic liposomal formulation will be performed in Cytori’s San Antonio Texas facility. Cytori’s facility features a new manufacturing clean room and technology specifically designed for the manufacture of complex liposomal compounds integrating cytotoxic compounds. In addition, Cytori has in house analytical chemistry capabilities to ensure its products are manufactured to the highest quality standards.

Final sterile packaging and fill finish activities will also be performed in the United States by Bryllan, located in Brighton, Michigan. Bryllan is a premier commercial scale contract manufacturing organization capable of safely filling potent and cytotoxic compounds, hormones, antibodies and complex biologics, live viruses and vaccines. Bryllan features a state-of-the-art aseptic production facility using isolators as the core technology with the highest engineering standards of design and construction to meet US FDA and other global regulatory standards.

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Update on ATI-0918 30 Apr 2018 08:07 #11721

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Hopefully, the news release today will offset S-1 news on Friday - close today over .30 would be great imo.

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Update on ATI-0918 30 Apr 2018 08:07 #11722

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Well that's a lot of paragraphs to say basically nothing...LOL
Still, they need something to attract buyers for $10 million worth of stock.
If this is all that they have I expect product sales reported in about 10 days will once again prove to be quite dismal :puke:

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Update on ATI-0918 30 Apr 2018 10:32 #11723

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Hedge, you are correct that he PR was like the Seinfeld show about Nothing. The intent was to water down the S-1. Is my recollection correct that they said they would NOT proceed with the Azaya drug candidates without a partner to finance? Did they ever address this inaccurate proclamation?

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Update on ATI-0918 30 Apr 2018 10:35 #11724

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myownhedgefund wrote: Well that's a lot of paragraphs to say basically nothing...LOL
Still, they need something to attract buyers for $10 million worth of stock.
If this is all that they have I expect product sales reported in about 10 days will once again prove to be quite dismal :puke:


Agree - the announcement only had the purpose to "compensate" the S-1 - was poor and ignored any timelines.

This slide is 6 months old now, but gives a decent impression-



It looks like ATI-0918 could be the first money-spinner, but they have to find a partner first and collect from him. Noteworthy is the 8 Mio estimate towards EU approval on top of Oxford- stand alone that 10 Mio RO is clearly not sufficient. The question remains where is the rest coming from?
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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:

Update on ATI-0918 30 Apr 2018 12:09 #11725

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Fas
That timeline is already blown for ATI-0918
However, once they file in the EU how long do you estimate for approval ?

On your other point, the lasting of this cash soon to be raised, yep a early 2019 raise will be coming imho as I do not see any partner with a ounce of sense signing before the EU accepts their filing ...at the earliest.
As far as selling other parts of the company...I believe the Oxford terms are the current issue...what is it...debt down to $3 million before the patent lean is released ?

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Update on ATI-0918 01 May 2018 13:57 #11726

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myownhedgefund wrote: Fas
That timeline is already blown for ATI-0918
However, once they file in the EU how long do you estimate for approval ?

On your other point, the lasting of this cash soon to be raised, yep a early 2019 raise will be coming imho as I do not see any partner with a ounce of sense signing before the EU accepts their filing ...at the earliest.
As far as selling other parts of the company...I believe the Oxford terms are the current issue...what is it...debt down to $3 million before the patent lean is released ?


I do not think "accepting EMA" filing is pre-requisite for a deal- you and I are pretty clue-less on that business- but guessing is permitted- mine would be once they have successful production tests.

On money requirements from January 1, 2018 to say mid -2019, when launches could happen for ADRESU and ATI-0918, one does not have to have an accounting degree-

My reasonable guess- 2,5 Mio operating cash-burn p/Q =15 Mio plus Oxford 14 = 29 plus from the slide 2 Scleroderma Japan, 8 ATI EU + 8 scleroderma US makes 47 Mio, instead of the 9,5 they started with and the 9,5 they might raise.

To me I see a probability of 80-90% for Scleradec II to meet its 12 weeks primary endpoint- I also think they can find an ATI partner for EU. It all depends what these two events will do to the bank account and PPS.

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Update on ATI-0918 01 May 2018 15:37 #11727

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***I do not think "accepting EMA" filing is pre-requisite for a deal- you and I are pretty clue-less on that business- but guessing is permitted- mine would be once they have successful production tests.***

Sure, but its not the act itself that this represents to me. This, and to me any reasonable partner, represents past the fuck-up stage to put it bluntly.
This company screws nearly everything they touch up...so acceptance means they have passed what was needed in the Texas lab and have gotten all their paperwork correct for the EU to proceed towards approval.
Why would anyone, given this company's history roll the dice before these events ???
Calhoun thought he had Japan in the bag...nope...and we still pay for the loan mistake.

Anyway...did you give any thought on how long the approval process will be for ATI-0918 once they file ?

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Update on ATI-0918 02 May 2018 07:59 #11728

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myownhedgefund wrote: Anyway...did you give any thought on how long the approval process will be for ATI-0918 once they file ?


It does not makes sense, to think about something that I do not know about. At a minimum, what I understood from Franshei, that the rules of the game are totally different for those generics compared to a new drug and its approval process. We could definitely use Franshei´s knowledge at this stage of the game, but unfortunately he prefers to sulk in the background.

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Update on ATI-0918 02 May 2018 09:12 #11729

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fas wrote:

myownhedgefund wrote: Anyway...did you give any thought on how long the approval process will be for ATI-0918 once they file ?


It does not makes sense, to think about something that I do not know about. At a minimum, what I understood from Franshei, that the rules of the game are totally different for those generics compared to a new drug and its approval process. We could definitely use Franshei´s knowledge at this stage of the game, but unfortunately he prefers to sulk in the background.


Very disappointed in Franshei - even if he bailed-out, he could have at least responded to my e-mails!:bash:

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Update on ATI-0918 02 May 2018 10:58 #11730

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I still find it hard to believe franshei's departure was lodge related, but who knows I guess
Hopefully it wasn't something more worrisome.
This article suggest 12 months for EU
globalresearchonline.net/journalcontents/v42-2/14.pdf

Speaking of old members...Fas...do you ever hear from DOV ?

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Update on ATI-0918 03 May 2018 04:39 #11734

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myownhedgefund wrote: Speaking of old members...Fas...do you ever hear from DOV ?


DOV/Lewis is still a facebook friend and I presume that will stay that way

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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:

Update on ATI-0918 03 May 2018 08:43 #11735

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***DOV/Lewis is still a facebook friend and I presume that will stay that way ***

That's good.
On and off in the last few months I've been thinking about old posters of the lodge.

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