Algernon Pharmaceuticals Inc (AGNPF)

[Money $hot]

The signing of the 21st Century Cures Act by the POTUS will be a banner day for Breathtec moving forward IMO >

Breathtec Biomedical Inc. (October 17, 2016)

Regulatory Pathway:

"Management has engaged regulatory consultants with extensive experience in medical device and in vitro diagnostics strategies to evaluate potential regulatory options to propel both the FAIMS and NaNose technology platforms to market. The Company has further engaged experienced product development consultants to initiate the design controls, and quality systems processes to meet regulatory approval and to lead the establishment of product manufacturing protocols as a precursor to commercialization."

breathtecbiomedical.com/2016/10/17/breathtec-biomedical-provides-corporate-overview/

Question: Does the above statement take into account soon to be revised FDA regulations under the 21st Century Cures Act?

Answer: Hmmm?

NA-NOSE Development:

"*NB this device may be labelled by FDA as a class III device if there is no predicate at the time of application and this would require a petition to lower class or ‘de novo’ 510(k)"

breathtecbiomedical.com/technology/na-nose/

Question: How long has it historically taken the FDA to clear 510(k) submissions? Meaning - cleared to market device.

Answer: See for yourself - EMERGO

"The resulting outcomes could immensely benefit patients and health care providers alike, and internal market studies increasingly show that commercial interest for portable breath analysis devices indicate a potentially global high-growth marketplace.”

breathtecbiomedical.com/2016/10/03/breathtec-biomedical-presents-point-care-strategy-international-breath-research-conference/

Stay focused my friends,

/////AMG

Focused?

I just conducted a Q & A Selfie...