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Understanding the Clinical-Development Pathway Required by the FDA and EMA: An Expert Analyst Discusses His Strategy in Investing in Biotech Stocks

67 WALL STREET, New York - April 29, 2013 - The Wall Street Transcript has just published its Biotechnology and Pharmaceuticals Report offering a timely review of the sector to serious investors and industry executives. This special feature contains expert industry commentary through in-depth interviews with public company CEOs and Equity Analysts. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.

Topics covered: Health Care - Biotechnology and Pharmaceuticals - Executive Officer Interviews - Biotechnology and Pharmaceutical Investing - Orphan Drug and Biologics Manufacturing - Biotechnology and Pharmaceutical Companies Valuation

Companies include: Gilead Sciences Inc. (GILD), Idenix Pharmaceuticals Inc. (IDIX), Achillion Pharmaceuticals, Inc (ACHN), Vertex Pharmaceuticals Incorpo (VRTX), Cubist Pharmaceuticals Inc. (CBST), Optimer Pharmaceuticals, Inc. (OPTR), Theravance Inc. (THRX), InterMune Inc. (ITMN), GlaxoSmithKline plc (GSK), Eli Lilly & Co. (LLY), Merck & Co. Inc. (MRK), Alexion Pharmaceuticals, Inc. (ALXN) and many more.

In the following excerpt from the Biotechnology and Pharmaceuticals Report, an expert analyst discusses the outlook for the sector for investors:

TWST: What is happening in the regulatory environment right now that creates either challenges or opportunities for your companies?

Mr. Skorney: The regulatory environment has actually been fairly favorable over the last year and a half to two years. I think it struggled with - the FDA approvals I've seen in my space over the last two years, which has really accelerated compared to the last five, six or seven years of history.

I think part of that is driven by companies that are clear in what the FDA wants in terms of an application for filing and have been more diligent in trying to produce the data that the FDA wants, but I think there has also been a bit of a pendulum swing back from the FDA where they're loosening the restrictions. But certainly they are willing to take on a little bit more risk than maybe they did four or five years ago.

TWST: What industry-specific metrics do you think are most meaningful for evaluating biotech stocks that investors in the sector should be sure they understand and analyze?

Mr. Skorney: I think it's a bit of an esoteric field, and some metrics around those few large-cap names and even kind of p/e multiples, I think, are somewhat open to interpretation. I think it's very important for investors, more than anything, to familiarize themselves with the clinical-development pathway that's required by the FDA and the European Regulatory Agency, the EMA, because I think that's what's most in backfall to any of these companies - kind of coming up with a reasonable probability that a company is going to go from one point to the next point, that has become the major value inflection points for these therapeutic-focused companies...

For more of this interview and many others visit the Wall Street Transcript - a unique service for investors and industry researchers - providing fresh commentary and insight through verbatim interviews with CEOs, portfolio managers and research analysts. This special issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.