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InterMune, Inc. Message Board

  • cpasific cpasific Jul 15, 2013 12:57 PM Flag

    Over $15 very soon, buy out may be at 100% premium. $20 at the least

    Shorts better cover.

    Sentiment: Strong Buy

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    • does anyone know when FDA approval is expected?

      • 3 Replies to ricksiddiqi
      • There was a mention of some ongoing data collection, leading to Ph 3 data not being entirely complete until April. Definitely can turn the prelim findings within a couple weeks. Team submission process last time around was outrageously slow...needed some outside help to get it right, which they very nearly did. With new regulatory head and CMO - who actually know what they are doing - it is very likely company will invest heavily in the re-submission. FDA turn on that will be faster, because all the prelim work of the filing is on record. My guess is, 3-4 months for submission package to FDA and 3-4 month decision. If data are strongly positive, there will be heavy pressure to go faster, i.e., drug available in Japan, EU, Canada, but not US ?? FDA got it wrong the first time ?? Data also continue to pile up on long term follow-up of US CAPACITY Trial patients. My over under, with strongly positive data, is not more than 5 months total from prelim data release to approval. I'm under.

      • Late 2014. June is too optimistic. Primary study completion say end of January. Very aggressive 2 months for analysis, very aggressive same-day resubmission, and slightly optimistic 6 months for review gives late September. If certain politivermin seriously cut FDA funding, though, we could turn to Spain, SPAIN, I tell you.

      • next june

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