Tag Archives: CINV

Business, Finance, Occupation & Industry

Avoid This Pharma Stock

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By Dan Dzombak, The Motley Fool

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Editor’s note: This article is a stock pitch made by a member on CAPS, The Motley Fool’s free investing community. The pitch is published unedited and is the opinion of the CAPS member whose pitch it is, in this case: zzlangerhans.

Each week I cull a top stock idea from the pitches made on CAPS, the Motley Fool‘s 180,000-member free investing community. Want your idea considered for this series? Make a compelling pitch on CAPS with a minimum length of 400 words. Want to follow the weekly picks? Follow me on Facebook or Twitter.

Company

AP Pharma

Star Rating (out of 5)

*

Industry

Health care

Market Cap

$177 million

 

AP Pharma Underperform Pick

zzlangerhans

Member Rating

99.66

Submitted On

3/26/2013

Stock Price At Underperform Recommendation

$0.63

Sources: S&P Capital IQ, Yahoo! Finance, and Motley Fool CAPS.

This Week’s Pitch:

I’ve watched from the sidelines as AP Pharma stock ran and sagged ahead of the APF530 PDUFA, likely the result of a self-fulfilling prophecy of the “run-up” enthusiasts. As always, it is good to be an early adopter of manufactured momentum plays in low float stocks and painful to be late to the party. Getting back to fundamentals, I see AP as a prime candidate for a post-PDUFA decline regardless of outcome. In my mind, the company’s goose was cooked when results of the phase III trial indicated that APF530 was equivalent but not superior to the standard of care Aloxi. The smart money abandoned the stock and the next few years were a blur of CRL, time and resource-consuming studies, and dilution. The penny stock share price masks a startling 193M market cap, the result of a massive dilution last July that suggests the company is already looking ahead to their next act after APF530. Even if approved, APF530 is unlikely to become a significant player in the generic-dominated CINV market.

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The article Avoid This Pharma Stock originally appeared on Fool.com.

Fool contributor Dan Dzombak can be found on Twitter @DanDzombak or on his Facebook page, DanDzombak. He has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools …read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

A.P. Pharma Receives FDA Complete Response Letter for APF530

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By Business Wirevia The Motley Fool

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A.P. Pharma Receives FDA Complete Response Letter for APF530

– Company Revises Projected Launch Timing from 2H 2013 to 1H 2014 –

– Conference Call to Be Held at 8:30 a.m. Eastern Time –

REDWOOD CITY, Calif.–(BUSINESS WIRE)– A.P. Pharma, Inc. (OTCBB: APPA.OB), a specialty pharmaceutical company, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for its lead product candidate, APF530, for the prevention of chemotherapy-induced nausea and vomiting (CINV). The CRL describes the following issues that must be addressed.

  • With respect to chemistry, manufacturing and controls (CMC), the FDA has requested the refinement of one product quality analytical test method, and that certain deficiencies identified during facility pre-approval inspections be addressed.
  • The FDA has requested that a human factors validation study evaluating the usability of the APF530 syringe system together with its proposed product labeling and instructions for use be conducted with product assembled using a validated, commercial process.
  • With respect to clinical, the FDA has requested a re-analysis of the existing Phase 3 clinical data that reclassifies patients into those receiving moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC) according to the recently modified ASCO 2011 Guideline. The FDA did not request any new clinical studies.

“We appreciate the FDA‘s thorough review of the APF530 NDA,” stated John B. Whelan, A.P. Pharma’s president and chief executive officer. “While disappointed in today’s notification, we believe that the issues raised in the CRL are addressable, and we remain firmly committed to the successful development of APF530, which we believe will fulfill an important unmet need and improve the lives of patients suffering from CINV. In order to allow us time to carefully address the issues raised in the CRL, we are now projecting product launch for the first half of 2014, versus our prior guidance of the second half of 2013.”

Conference Call Details

A.P. Pharma will host a conference call on Thursday, March 28, 2013 at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). Interested investors may participate in …read more
Source: FULL ARTICLE at DailyFinance