BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX)

The stock gapped up on news that an bird flu outbreak has once again hit China. Only problem is the spokesman came out and said BioCryst has no patents in China and will not make a dime from the outbreak. Go figure

As I predicted, BioCryst still had a little life left which allowed me to escape my green thumb and flip turn into a red one. 33% jump today, and all because of this:

BioCryst Pharmaceuticals, Inc. today announced that it received a preliminary comment letter from the U.S. Food & Drug Administration (FDA) that outlines a pathway by which BioCryst could file a New Drug Application (NDA) seeking regulatory approval of intravenous (i.v.) peramivir.

That's just about the weakest endorsement I've ever heard. The FDA sees how BioCryst can actually file an NDA for peramivir, despite the drug having failed in pivotal trials. That of course does not describe a path towards FDA approval or even NDA acceptance, just NDA filing. All this development means is that BioCryst will expend more resources in a fruitless quest for approval of peramivir. Meanwhile, BARDA has simultaneously instructed the company to stop work on the DoD peramivir project. Doesn't sound like the same government is salivating to improve this drug.

Clap louder!!
Tinkerbell is dying!!!
Somw iseas just cannot be made to work and cannot be marketed competitively if they do.

BB

Multiple drug candidates for partnerships (gout and Hep C)

Antiviral IV Peramivir for govt. stockpiling and future commercialization. There are no IV antivirals for hospitalized patients.

Will rise during next pandemic flu. When will that happen? I have no idea, but at this cheap price, it's not that hard to wait.

Struggled the past year. Will correct.

a product that's been proven 90% successful in worst case flu situations, EUA with full approval within 12 months maybe sooner, stockpiling orders lined up, 3 years of cash on books, strong potential gout drug in pipline...what's not to like...

following tmf on this one

The "Emergency Use Authorization" Bcrx is pushing the stock in the short term. Production of their life saving IV drug "Peramivir" is currently limited. The final authorization to use the anti viral drug will coincide with the ramping up of production capacity, all to give this stock a steady upwards rise for many quarters.

If flue turns really bad, these guys have an IV solution. Working hard for international sales.

From the president's council recs “HHS is moving forward with the purchase of intravenous antivirals for use under EUA for individuals who may require them.” $2.7B has been identified for anti-virals and vaccines; peramivir will be stockpiled, and an EUA will be coming shortly. If this doesn't happen, the stock will tank and many more people will die from H1N1 than should have.

N1H1 Viris Drug

Expect FDA approval of its anti-viral and substantial orders thereafter.

Speculative play based on bullish sentiment from Michael Murphy; big potential if Emergency Use Authorization is granted in the next few weeks.

Swine Flu vaccine, need I say more...

Swine flu? Are you kidding me? This will blow over and these companies will have produced enough product for billions of people who are all perfectly healthy. Thanks, 24-hour news cycle, for making a mountain out of a molehill...

Biocryst still has some time before it will be able to get peramavir approved. Although peramavir is a slam dunk, Biocryst will still lose plenty before it makes gains. I'd wait until peramavir (intermascular and I.V.) gets pushed into phase three in the US.

Biocryst is sitting on the verge of a major break through for the marketing of a drug to combat influenza in the health care sector.

A real and announced satisfactory continuing positve testing program would start kick this drug developing company into high gear with the capability to fly with the big boys.

Ground floor opportunity with a perceived good odds of success with one drug and others in varius stages of formulation and development.