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Celldex Therapeutics, Inc. Message Board

  • nickdidomenico nickdidomenico Nov 19, 2012 2:32 PM Flag

    Long, can CLDX go it alone with 11?

    At the start of the year the conventional wisdom is that they needed a Partner, in your view does this still hold? Will we see a PT or will the entire company likley be sold, if the latter then why not just sell 11 once FDA gives it the clear path to approval?

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    • To a large degree the next step is based on the end-of-PII discussions with the FDA. If the FDA is OK with a single arm, relatively small pivotal PIII for 011 then CLDX will run the trial on its own. If the FDA wants a larger, randomized PIII then most likely CLDX will partner 011. However, either way- sooner of later- CLDX will likely partner 011 because triple negative BC is a large indication that requires substantial resources. Even more so if CLDX wants to expand 011 to 3 additional cancer indications as AM mentioned at the Lazard conference.

      I don't think the company will be sold, at least not in the near term. Rindo and CDX1135 are targeted at orphan disease indications, with patient populations small enough that CLDX could handle manufacturing and distribution. Along with an 011 partnership, CLDX could build substantial value before looking for a buyer.

      • 2 Replies to long_vrts2
      • FDA has in the past from time to time approved oncology drugs based on single-arm phase II-trials and a few more based on randomized phase II data. Phase III - by definition - is prospectively randomized two- or more arm-trials.

        T-DM1, an ADC targeted for HER2+ breast cancer, had strong single-arm phase II data and got a refuse-to-file-letter from FDA in summer 2010 and, hence, needed to present randomized phase III data for filing in 2012. Approval is pending.

        CLDX has over 77 mio$ in cash (acc. to the CEO's recent presentation at Lazard) which puts them in a strong position for license talks as they can last "well into 2014" (Marucci) based on current activities.

      • Thanks Long

        What is your take on what the FDA will require re 011 and when isda decision likley?

    • Nick, I appreciate the knowledge that Long has, but why do you guys look to him as though he is the oracle? He is mostly likely as in the dark as most except if he has inside scoop on things.

      I'm sure he would have us do our DDs ourselves without looking to him to save us.

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