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TOPIC: CYTX Reports Filing of Pre-Submission Request for New Drug Application

CYTX Reports Filing of Pre-Submission Request for New Drug Application 07 Mar 2019 07:38 #12645

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CYTX files for formal new drug application pre-admission request to EMA for Doxorubicin Hydrochloride Cytori.

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CYTX Reports Filing of Pre-Submission Request for New Drug Application 07 Mar 2019 07:40 #12646

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CYTX Reports Filing of Pre-Submission Request for New Drug Application 07 Mar 2019 08:01 #12647

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It looks and sounds like business as usual, which is kind of assuring. Next up will be the year-end call, probably next week Thursday? My water tells me they do not want an Public Offering but are working on an other solution.

As usual - time will tell.

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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:

CYTX Reports Filing of Pre-Submission Request for New Drug Application 07 Mar 2019 08:27 #12648

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fas wrote: It looks and sounds like business as usual, which is kind of assuring. Next up will be the year-end call, probably next week Thursday? My water tells me they do not want an Public Offering but are working on an other solution.

As usual - time will tell.



This release confirms that the ballgame is certainly not yet over - hopefully, they will come up with another solution rather the S-1, but I will believe that when I see it - LOL.

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CYTX Reports Filing of Pre-Submission Request for New Drug Application 07 Mar 2019 08:49 #12649

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fas wrote: It looks and sounds like business as usual, which is kind of assuring. Next up will be the year-end call, probably next week Thursday? My water tells me they do not want an Public Offering but are working on an other solution.

As usual - time will tell.


From what you told me Fas, the last Raise has language in it to allow conversion at the next offering pps. Haven’t converted mine yet and waiting in anticipation to see what the next offering will be prior to converting.

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CYTX Reports Filing of Pre-Submission Request for New Drug Application 07 Mar 2019 10:26 #12650

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My tea leaves may stain your water Fas...LOL
I say they are pulling every lever to attract buyers to this offering as it has likely fallen very short of both $10 million and the Oxford required $7.5 million goals.
This filing means very little other than they will still burn many millions before a formal filing.
I'll throw one more stick on the fire....it also seems to indicate they have fallen even further behind with a launch (a assumption) that may not now come until 2021.

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CYTX Reports Filing of Pre-Submission Request for New Drug Application 08 Mar 2019 05:26 #12651

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Your tealeaves -of course- could be telling the correct chain of events. At this point in time, with massive uncertainty, an announcement relating to the "normal course" of business I view already as positive that they are still "at work". They should have already >10 years of experience that such announcements do not make a dent in PPS, so "pulling every lever" is not an argument of any substance.

I do agree- they would hardly find folks - RIGHT NOW- under present conditions- that would put up 7,5 Mio at present, so I am looking for something different, whatever that will be- according to the Oxford filing a business combination or sale of an asset. Of course very good news- partner, scleroderma etc would jack up PPS and could make a PO again a viable proposition too.

As always- time will tell- looking forward to the CC.

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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:

CYTX Reports Filing of Pre-Submission Request for New Drug Application 09 Mar 2019 06:43 #12652

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Totally agree such releases have zero meaningful effect on PPS but that was not what I was trying to convey, rather it was simply to draw attention to the company. e.g. something Maxim or whomever can point to as progress.
As far as a business combination or sale....there has been plenty of time for such a event to happen so the "tea leaves" there suggest that if such interest has been expressed in the past, management didn't like what was being offered. I see no reason for a pursuer to suddenly bump up a offer at this late date so such a event may be necessary despite the prices or terms offered. Now I could be completely wrong here but I don't remember any company spending money on a pre-submission press release. Such things usually mentioned in calls or filings. To me, its classic penny stock fluff.
Fas is right that time is short and next we get the call. Heck, its been a long time since I listened to a Cytori call...maybe I'll listen in for old times sake....LOL
BTW...for those interested in the OT stock VSTM, which is at fresh 52 week lows this week, they report on March 12.

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CYTX Reports Filing of Pre-Submission Request for New Drug Application 09 Mar 2019 12:43 #12653

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Not shocked either about little price impact. I think this news matters for penny stock stem cell company like CYTX. Kept trying to find out what was the status of stability studies. For a 503b-like submission (ANDA-like) of the dox liposome product, the review should be much easier. More so, they delivered finally but think market is basically wondering, are you a stem cell company or generics. Anyway, think Hedge is right--it's publicity to advertise companies that may be interested in a deal. Three weeks to go so gonna be tricky navigation. Now almost 6 months since the sclero French data should be locked so not sure what they are waiting for. if it was truly bad, would have been out and done. lots of biotechs are consolidating or exiting. Oncternal just reverse merged with GTXI which skyrocked. they had cash but Cytx has a potential asset which could be monetized. It could also be the end and life support are in place. we shall see

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CYTX Reports Filing of Pre-Submission Request for New Drug Application 10 Mar 2019 10:01 #12654

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We shall see yes.

Just to bring up what Girao said at the last call on business development in general-

Kolbert-
Perfect. Thank you guys. So one last question, can you just give us some hints as to how active the BD is around ATI-0918 and clearly there's a hope to monetize that asset and bring non-dilutive capital into the Company. Can you just give us some idea of how the progress is going in terms of that effort? Thanks.
Tiago Girão
Yes. Anything about BD is always working problematic. But there is a lot of interest for that particular drug in Europe. You can imagine that there's – as I mentioned about a $120 million to perhaps as well over $200 million a year market opportunity with that drug.

We think there is the opportunity to be the first or second generic. If we can monetize it in a way that we think it’s fair to the opportunity and shareholders in the near-term, we'll do it. However, we think that the longer we go, the closer we get to the goal line that the opportunities for that maybe improve as a little bit competition potentially for partners.
So we're out there in the market aggressively talking about European licensure, but we'll wait for the right deal comes along. There's also interest in, call it tertiary market regarding that drug being a high quality U.S. maker drugs that it had a lot of stumbles were made in outside of the U.S., even in the U.S. Here is real opportunity to position that for outside of Europe, and there is some opportunities related to there. So we're actively engaged in weekly discussions with potential partners and developments related to that.

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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:

CYTX Reports Filing of Pre-Submission Request for New Drug Application 10 Mar 2019 14:31 #12655

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If nothing else Monday should have the earnings date announcement.
Agree with Fas, Thursday has been the historical day.

As far as JK., He must be quite a gardener as he always has a over supply of carrots to serve. :grin:

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