rsv fda fastrack, page-2

Sunrise2000 - thanks for this - missed the news totally.

Modest SP rise of 4.55% on Nasdaq, but that is against a much larger SP slide of late (possibly a bit premature given they still have plenty of cash and a possible catalyst if Vapendavir Phase 2b SPIRITUS trial results kick arse in second half of 2016).

And now they have a second possible nearer term trigger with BTA 585 receiving FDA Fast-track status.

Savvy Nasdaq investors might spot this news and dip their toe in over the coming week or so - let's see whether any analysts start to spread the word or even initiate coverage.

Here's the PR:

http://investors.biotapharma.com/releasedetail.cfm?ReleaseID=955037

Feb 16, 2016
Biota Receives FDA Fast Track Designation for Its Antiviral BTA585 for the Treatment of Respiratory Syncytial Virus Infections


ATLANTA, Feb. 16, 2016 (GLOBE NEWSWIRE) -- Biota Pharmaceuticals, Inc. (NASDAQ:BOTA), a biopharmaceutical company focused on the discovery and development of direct-acting antivirals that address infections that have limited therapeutic options, announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its antiviral compound, BTA585, for the treatment of respiratory syncytial virus (RSV) infections in infants, young children and adults. The FDA Fast Track process is designed to expedite the development and review of drugs used in the treatment of serious or life-threatening conditions and which demonstrate potential to address unmet medical needs.
"There are no direct antiviral products approved to treat the millions of RSV infections that occur each year in the U.S. and we are pleased that the FDA has recognized BTA585 and its potential to address this significant unmet medical need," remarked Joseph Patti, PhD, president and chief executive officer at Biota. "Fast Track designation is another positive step for BTA585 and its development for the treatment of respiratory infections in children and adults."
BTA585 is an oral RSV fusion inhibitor in development for the treatment and prevention of RSV infections. BTA585 has successfully completed a Phase 1 single ascending dose trial and has recently completed dosing in a multiple ascending dose trial with results expected to be reported this quarter. A Phase 2 RSV challenge trial is expected to begin in the second quarter of 2016.

About Respiratory Syncytial Virus (RSV)
RSV is a major cause of acute upper (colds) and lower (pneumonia and bronchiolitis) respiratory tract infections in infants, young children, and adults. Each year in the United States, RSV accounts for an estimated 2.1 million medical visits in children under the age of five, with many of the children afflicted requiring hospitalization.