SOURCE: Paragon Financial Limited

Paragon Financial Limited

September 21, 2011 08:16 ET

Tougher FDA Approval Process Weighs on Biotech Sector

The Paragon Report Provides Equity Research on MannKind and Celsion

NEW YORK, NY--(Marketwire - Sep 21, 2011) - The Paragon Report examines investing opportunities in the Biotechnology Industry and provides equity research on MannKind Corporation (NASDAQ: MNKD) and Celsion Corporation (NASDAQ: CLSN). Access to the full company reports can be found at:

In recent years the FDA has been heavily scrutinized for making the approval process more difficult for drug developers. A groundbreaking study released this year by the BIO and BioMedTracker finds that the overall success rate for drugs moving through clinical trials to FDA approval from late 2003 to the end of 2010 is a mere 10 percent. Previously, the rate of approval was one in five to one in six. Oncology drugs faced the toughest road to approval despite the fact that the disease area is the most closely studied in all of drug development.

Janet Woodcock, the head of the FDA's drug division, is quick to dismiss concerns regarding the FDA's approval process. This summer in testimony before the House Energy and Commerce's health subcommittee, Woodcock explained the agency meets more than 90% of deadlines that are part of the drug review process. She also said so-called first cycle approvals are at a 20-year high with more than two-thirds of new drugs being approved within the six-to-10-month time frames given to new drug applications.

The Paragon Report provides investors with an excellent first step in their due diligence by providing daily trading ideas, and consolidating the public information available on them. For more investment research on the biotechnology industry register with us free at and get exclusive access to our numerous stock reports and industry newsletters.

MannKind's leading drug candidate, Afrezza, is an ultra-rapid acting inhalable insulin that (if approved) will allow diabetes patients to inhale Afrezza before a meal. Last month the company announced that it has confirmed with the US Food and Drug Administration the design of two clinical studies that evaluate the efficacy and safety of Afrezza.

Celsion is an oncology company dedicated to the development and commercialization of innovative cancer drugs, including tumor-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems. For the second quarter ended June 30, 2011, Celsion reported a net loss of $6.9 million, or $0.42 per share, compared to a net loss of $2.6 million, or $0.22 per share, in the same period of 2010.

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