Algernon Pharmaceuticals Inc (AGNPF)

[Money $hot]

House approves the 21st Century Cures Act, sending landmark bill to Senate

Excerpts:

"The House of Representatives passed the 21st Century Cures Act by a 392 to 26 vote, showing a bipartisan spirit that has been rare in recent years. The Cures Act now heads to the Senate, for a vote early next week."

"The Cures Act includes numerous provisions that set the stage for the faster approval of prescription drugs and medical devices. Although proponents claim these new measures will not lower safety standards, numerous critics, including some former Food and Drug Administration officials and national consumer groups, disagree. They have argued that FDA already moves faster than similar agencies in other countries."

"But party leaders on both sides of the aisle said they expect the bill to pass the Senate."

www.statnews.com/2016/11/30/21st-century-cures-act-house/

AdvaMed Commends Revised 21st Century Cures Package

Excerpts:

“Patients are looking to medical technology companies to develop the next generation of life-saving, life-enhancing devices and diagnostics. These advancements are key to solving the nation’s health care challenges, as greater patient access to innovative technologies generates efficiencies and cost savings for the health care system while improving the quality of care."

“The package includes a number of important improvements to FDA’s medical device premarket program designed to increase the efficiency, predictability and transparency of the agency’s review process. The most significant of these builds on initiatives already underway within FDA to help create an expedited pathway for breakthrough medical technologies – "

www.advamed.org/newsroom/press-releases/advamed-commends-revised-21st-century-cures-package

This is bigger than most people realize IMO. The US Senate will Tee It Up for a vote next week.

Breathtec Biomedical Inc - Go Long

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P.S. There is already an FDA expedited/fast path to market for medical devices (2 years). New legislation narrows a path down to No Clinical Trial Necessary depending on type of device and strength of "Real World" documentation. This could get very interesting folks...