InterMune [NASDAQ:ITMN] trading halts awaiting news |
Biotechnology Companies | |||
Written by Hugh McManus | |||
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Trading in shares of InterMune halted today at 1 p.m. ET in anticipation of news from the FDA. ITMN opened at $47.74 and last traded at $45.44. Signs are that the FDA will give some news today, the PDUFA date for pirfenidone. History tells us that the FDA is conservative. Walk into the HQ in Washington DC and you're greeted by pictures of the hero that "saved" the US from thalidomide. Despite criticisms of the agency, it is more concerned about being wrong than it is of being right. Perhaps the pricing in put options is testament to the concern that people feel about pirfenidone: it has some legitimate safety concerns. It also has only one good, phase III trial. It should have two to assure approval. It's anyone's guess what will be announced later today. It seems that people believe that there is downside: approval may be delayed in favor of more clinical data or approved with some really major caveats.
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