Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
We consider the agency our partners with the goal of ensuring healthcare safety. In alignment with this commitment, we have made it an organization-wide priority initiative to continually optimize quality systems and processes, including completing and submitting an Investigational New Drug (IND) application.
NEWS out from CRYO regarding FDA
American CryoStem Statement on the Receipt of a Warning Letter from FDA
EATONTOWN, NJ / ACCESSWIRE / January 8, 2018 / American CryoStem Corporation (PINK SHEETS: CRYO)) today issued a statement acknowledging that it has received a warning letter issued by the U.S. Food & Drug Administration (FDA) dated January 3, 2018 relating to its adipose derived stem cell product and its production facilities. This action follows the earlier inspections of the Company's New Jersey facility by the agency between July 17 and July 26, 2017.
CRYO CEO, John Arnone commented, "We take any comments or suggestions by the U.S. FDA very seriously. We have initiated the changes in response to the FDA's initial observations dated July 26, 2017. With regard to quality and cGMP compliance matters, we stand by our commitment to fully comply with the cGMP quality standards at our facility. We will further respond with an updated comprehensive plan to address FDA's updated observations contained in the letter received January 3, 2018, within the stipulated time-frame of 15 business days. We will actively engage with the agency to resolve these issues and continue to improve our quality systems and processes, as an organization-wide priority."
We consider the agency our partners with the goal of ensuring healthcare safety. In alignment with this commitment, we have made it an organization-wide priority initiative to continually optimize quality systems and processes, including completing and submitting an Investigational New Drug (IND) application.
About American CryoStem Corporation: American CryoStem Corporation (PINK SHEETS: CRYO) was founded in 2008, and has evolved to become a biotechnology pioneer, standardizing adipose tissue-derived technologies (Adult Stem Cells) for the fields of Regenerative and Personalized Medicine. The Company operates a state-of-art, FDA-registered, clinical laboratory in New Jersey and licensed laboratories in Hong Kong, Shenzhen, China and Tokyo, Japan, operating on our proprietary platform, dedicated to the collection, processing, bio-banking, culturing and differentiation of adipose tissue (fat) and adipose-derived stem cells (ADSCs) for current or future use in regenerative medicine. CRYO maintains a strategic portfolio of intellectual property (IP) that surrounds our proprietary technology that supports a growing pipeline of stem cell applications and biologic products. We are leveraging our proprietary platform and a developed product portfolio to create a domestic and global footprint of licensed laboratory affiliates, physician's networks and research organizations who purchase tissue collection, processing, and storage consumables from our Company. Our laboratory stem cell bank/line products are characterized adult human Mesenchymal Stem Cell (MSC's) derived from adipose tissue that works in conjunction with our patented (non-animal) medium lines. The Company's R&D efforts are focused on discovering, developing and commercializing ADSC therapies by utilizing our standardized collection-processing-storage methodology and laboratory products combined with synergistic technologies to create jointly developed regenerative medicine applications and intellectual property.
Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management's current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may," "will," "should," "expects," "plans," "intends," "anticipates," "believes," "estimates," "predicts," "potential," or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults, currency exchange rates, interest rates, persistency levels and frequency/severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues.
The company assumes no obligation to update any information contained herein.
SOURCE: American CryoStem Corporation
© Copyright © 2018 Accesswire. All rights reserved.
more good volume today and we are UP again.. will it hit .35 this week?
well stated and 100% correct.. someone is picking up some cheap shares !!
very nice bounce back after the IDIOT jeff sessions comments yesterday !!
In my personal opinion, it's time to pick up some cheap shares here !!
wow, i agree w/ bubba for once !!
Im still holding STRONG and picking up cheap shares !!
BC of Jeff Sessions comment regarding Rec mj
https://azmarijuana.com/marijuana-news/jeff-sessions-just-launched-a-crackdown-on-legal-marijuana-states/
someone is getting some cheap CRYO shares..
this should POP soon !!
I'm liking the pull back to pick up MORE shares !!
Its funny ... you are up and in the green on the stock and you keep slamming him... IMO this stock can ONLY go up from here !!
Nose dive?? REALLY? lol we will all make money just let the guy run the company already !! I'm in the green !! all good for me !!
I wonder if Andrey knows he needs Prs'? lol
Oh, Tijuana airport...
I'm picking her up San Diego airport...
thank you for the quick response and all your DD...
I'll be picking up a friend from the SD airport here in 12 days, where are they selling their products at as i will stop by too !!
MCIG is on fire in the mj market and now making things happen in Cali !! !!
Let's hope so !!
Cant wait to see what 2018 brings for MCIG shareholders !!
i would assume there is something brewing here ... time and patience's should be rewarded in 2018..
and as USUAL ...ANOTHER year and NOTHING from this company !!LMAO !!!
SELL THE SHELL to a REAL COMPANY w/ VISION and that can COMMUNICATE to the shareholders and market !!
NEW year coming and NEW MCIG !!
so with it hanging in there and up from the .01 range you think its a buy or not a buy? IMO i think it will take off in the near future !!
nice volume the last week and nice buying !! 2018 will be a GREEN YEAR !@!
Very nice volume today !!
i agree w/ BIG things coming... if you can take them out, you will be making a BOAT LOAD very soon !!
i think the 900k shares was a bluff to see who would sell on the bid !! Just My opinion .. we will see soon !!
2018 should be nothing but GGGGRRREEEEEEEEENNNNN imo for OMHE shareholders...
looks like the Market is LOVING MCIG !!! Green and going greener i n 2018 !!
Nice volume first thing at the opening bell !!
nice volume
We have some good volume already today... lets hope we hear something SOON!! !!
MCIG will be GREEEEEEEEEEEEEEEEEEEEEN in 2018 !!
crossing my fingers things POP in the NEW YEAR !!
I'm sure we should hear something next week IMO... NEW year and hoping NEWER HIGHS !!
MCIG will CRUSH It in 2018 !!
Lets hope we hear some good news next week !!
im hoping for GREAT news up and share reduction soon !!
It should BOOM hopefully soon !!