Replies to post #26871 on Lifeline Biotechnologies Inc (LLBO)

[confirm]

Glad LLBO has CLASS 11 clearance....& is now in FDA discussions for the
OTC market Class1 clearance ( imagine walking into Walmart, Walgreens, Cosco, ordering on line
through Elephantzon (Amazon), ahh how easy to buy your life saving device... maybe I’ll buy (2)...an extra
for my sister who Never gets a Mammogram.


Cyrcadia, Inc. – 2017 Year End and 2018 Look Forward Newsletter
by admin | Feb 21, 2018 | News | 0 comments

Regulatory Clearance, Trials Recap
CI’s current US trial success has allowed us to utilize a Non-Filing Justification (NFJ) with the FDA, under our current FDA 510(k) Class II clearance, enabling CI to go to market. Additionally, CI and CA have contracted with two regulatory advisor contractors to drive to a Class I designation (Over the Counter and direct to consumer markets) allowing for entry into market without the scrutiny of a class II device (Clinical, prescribed by physician market), as the iTBra™ stands now. The intent is launch into both the consumer and Over the Counter (OTC) markets almost simultaneously with the clinical markets. Thus far, indications are favorable for this approach and we will be meeting directly with the FDA in the months to come, declaring our intent. We will report again on the meeting outcomes once definitive. Moreover, CI will pursue a Modified 510(k) through the FDA enabling the rapid expansion of the clinical markets. This does not preclude us from going to market with our existing 510(k), Class II clearance (see the NFJ position above), but will certainly enhance our visibility and buy-in from the medical/clinical community.

And to think a company can reach a $450,000,000 Million dollar market cap on foreign sales alone, a life saving
device that has NO FDA clearance (a Sepsis filter for Hospitals, that stock forum posters said would never happen, BUT it DID), yes that ...Co. is “Cytosorbents”...((If only I had bought more shares of it than the $2000 I put into the investment selling it in 2015 four $29,000 I wonder what will happen to the stock price when they get FDA clearance for the US market gives me thoughts of Mount Everest))...OR does it make me salivate over
my several million LLBO shares I hold...ahh yes Amazon.