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Celldex Therapeutics, Inc. Message Board

  • whippersnapper65 whippersnapper65 Nov 11, 2013 5:14 PM Flag

    Understand today's abstract information in the light of these later developments...

    The abstract reflects data as it was known in May. What we know since then is that Celldex management expanded the ReACT trial with a 75-patient "confirmatory" arm in August for the Avastin refractory patients. Clearly management saw something worth investigating further in pursuit of confirmation: "Based on early evidence of anti-tumor activity, including stable disease, tumor shrinkage and investigator-reported response, the Company has decided to add an expansion cohort of approximately 75 patients to better characterize the potential activity of rindopepimut in this refractory patient population" (press release August 12, 2013). Perhaps the patient with the complete response and high titer number was the first instance of what management has observed in more than just that patient since the abstract was submitted in May. We will find out on the 24th.

    We also know that Celldex has scheduled a conference call on the 25th to discuss the updated ReACT data the day after it will be presented at the scientific conference. Conference calls are Marucci's "tell": he doesn't schedule a conference call unless there is positive material news to discuss.

    So put it all together, and it is reasonable to project that the expanded confirmatory arm could make ReACT data robust enough to submit for early FDA approval.

    Sentiment: Strong Buy

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    • Nice analysis Whipper. I see your logic and it makes perfect sense. The data today is telegraphing good things are coming with Rindo. This is not a given, but it is likely IMO as the data presented shows clear efficacy with working mechanism of action (i.e. antibody titer production). As far as early approval, it is possible, but we need to catch a BREAKTHROUGH STATUS DESIGNATION COMING from FDA I think in order for that to happen. The full 75 patient cohort could provide the juice for that to happen early next year. Expedited approval with early submission is a certainty if the data continues to come in posiitve, but that may only save incrementally on the current timeframe for approval. People don't realize fully what is at stgake here. THESE PATIENTS HAVE BRAIN CANCER AND ARE GOING TO DIE IN ALL PROBABILITY without effective treatment and there is currently nothing available that works.

      Sentiment: Strong Buy

    • Whip, while I fully agree with your reasoning I think regarding hew hire position you jump the gun. There is no way Rindo will be approve in the next 1.5 years and I think they're looking for someone to get on board early so when approved they'll be ready with manufacturing, distribution, quality control, etc.
      But, definetly, the fact that they're doing CC tells that there is some goodies in the bag for us!
      Weight, the next catalyst is on 24-25. So, if CLDX going to $30 it will be then, not this week.

    • cldx could see $30 by the end of this week. Too many good things are happening.

      Sentiment: Strong Buy

    • Forgot to add too: also after May the Celldex website has advertised manager/director positions directly related to marketing approved treatments.

      Put it all together. Marucci is telling you that Rindo stands a good chance of being approved soon; the company is certainly acting as if that is the case. You have to read between the lines.

      Sentiment: Strong Buy

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