RiverBabe's Baby Biotechs

[riverbabe]

Vphm

Not the end of the world. A buying opportunity? Nice pick tie.

[mrmarket]

ViroPharma Incorporated (Nasdaq: VPHM) today announced the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding Cinryze(TM) (C1 Esterase Inhibitor [Human]) industrial scale manufacturing expansion activities. The FDA has requested additional information related to observations from the pre-approval inspection and review of the technical processes.

"We and our partner Sanquin will begin working immediately to respond to the FDA as expeditiously as possible," said Vincent Milano, ViroPharma's president and chief executive officer. "And, we plan to commence manufacturing industrial scale lots at risk in the first quarter of 2011."

Continued Milano, "We remain committed to provide patients with an uninterrupted supply of Cinryze. In addition to our efforts around our industrial scale, we expect our currently approved manufacturing process alone will yield up to 60,000 doses annually."

Love the revenue growth for VPHM..clearly peeps like their products.

[tiedyed1]

Vphm

ViroPharma Incorporated (Nasdaq: VPHM) today announced the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding Cinryze(TM) (C1 Esterase Inhibitor [Human]) industrial scale manufacturing expansion activities. The FDA has requested additional information related to observations from the pre-approval inspection and review of the technical processes.

"We and our partner Sanquin will begin working immediately to respond to the FDA as expeditiously as possible," said Vincent Milano, ViroPharma's president and chief executive officer. "And, we plan to commence manufacturing industrial scale lots at risk in the first quarter of 2011."

Continued Milano, "We remain committed to provide patients with an uninterrupted supply of Cinryze. In addition to our efforts around our industrial scale, we expect our currently approved manufacturing process alone will yield up to 60,000 doses annually."

[wooish]

IMO, VPHM would make a good short now.

[tiedyed1]

VPHM keeps going UP!

Check out what my little old VPHM has been doing.
52 week highs day after day!

Is anyone else here enjoying this ride, and how far will it go?
(I do not want my over-exhuberance to cloud my exit strategy and any feedback here is appreciated!)

-Adam

[peanuts]

I've been buying DNDN lately... waiting

Adding to my position this morning. Will be 66% full after today.

[peanuts]

I've been buying DNDN lately... waiting

[dmk112]

are you holding through approval or just playing the bounce toward the fda approval date but sell before 10/30?

I will sell...

[Duniyo]

are you holding through approval or just playing the bounce toward the fda approval date but sell before 10/30?

Holding biod through the 10/30 is naive. The probability of approval is very small. Their data is inclusive at best.

What biod management is doing is data smoothing and that is not going to work with FDA.


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http://www.duniyo.com/diary

[wooish]

are you holding through approval or just playing the bounce toward the fda approval date but sell before 10/30?

[dmk112]

DMK

Just curious, what do u know about BIOD? Are they pending FDA approval?

Yes, they are... Here is some info below from www.fdacalendar.com

Our lead clinical candidate is VIAject™, a very rapid-acting form of injectable human insulin for meal-time use by patients with Type 1 or Type 2 diabetes. VIAject™ is comprised of commercially available recombinant human insulin and our proprietary formulation of ingredients, all of which are Generally Regarded As Safe (GRAS) by the FDA. Our proprietary formulation delivers insulin in a form which more closely resembles the way a normal body uses insulin to help glucose enter the body's cells, providing energy that allows the body to function. Currently, insulin therapies are not delivered quickly enough to simulate the desired meal-time insulin spike. In tests to date, the VIAject™ formulation of insulin promotes a more rapid absorption, which more closely mirrors the effects of naturally produced insulin in non-diabetics thereby providing more effective blood glucose control. This novel therapy is currently undergoing two pivotal Phase III clinical studies. The two studies, one involving 400 patients with Type 1 diabetes and the other involving 400 patients with Type 2 diabetes, are comparing the effects of VIAject™ to Humulin®, the leading recombinant human insulin.

[wooish]

DMK

Just curious, what do u know about BIOD? Are they pending FDA approval?

[dmk112]

Still adding on this pullback on BIOD, there's support around $4 ish so that will be my last add. The PDUFA is 10/30 so there are a few weeks for a run up but time's running low.

Some others that I'm looking at: MNKD, CADX, MELA.

ALXA is dead... exactly why I will never hold stock through a decision. The FDA is unpredictable and they seem more clue less than anything. They cited concerns with P1 data but they approved it to P2... makes sense, right?

[wooish]

ALXA took a dump today. Ouch!

[riverbabe]

Alxa

I'm out. The Complete Response Letter does not bode well for Alexza's delivery system for any drug. The Letter said that "The agency also noted that decreases in FEV1 were recorded in subjects who were administered device-only, placebo versions of AZ-004. (my emphasis)