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Celsion Corp. Message Board

  • thomasb3982 thomasb3982 Sep 12, 2012 11:39 AM Flag

    Strong Thermodox Approval has to be on Way

    There is no way that DMC members and eventually the FDA can refute what appears to be a very successful trial.

    With so many people suffering from cancerous tumors, this HEAT platform NEEDS to be adopted.

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    • Thomas, while I agree with you that our technology needs to be adopted by the medical community, I'm afraid it's not that simple. We have clinical trials in order to generate the safety and efficacy data required to present to a regulatory body. And the clinical trial itself is a very important and necessary step, which is what I believe you were implying. However, there is no doubt that the FDA can indeed refute what appears to be a very successful trial -- they do it all the time. If the data -- or other additional requirements -- fail to convince them, it doesn't matter how many people are suffering from cancerous tumors or how successful the trial appears to be doing, it's invalidated until the criteria is met.

      We have a bit to go before we submit to the FDA and there are other factors beyond data that are also taken into consideration. Take Navidea Biopharmaceuticals (NYSEAMEX:NAVB), for example, not as a comparison to Celsion, but rather as an illustration of how what may seem as superfluous factors can affect FDA approval. On Monday the company received a complete response letter from the FDA, rather than an approval, because of issues relating to third-party manufacturing. The company is currently working to resolve the issues with the FDA and remains confident, however the stock is yet to fully recover. Like many other biotech investors, we are also participating in a high risk, high reward opportunity and, although we may like the odds, we should always do our own independent and thorough due diligence.

      This being said, I do believe that Tdox will emerge as the cancer answer if the data generates positive results and the additional FDA requirements are satisfied. And frankly, there is good reason to believe in a very successful pIII outcome. It better be, because the technology is just too irresistible. Good luck to you.

      Sentiment: Strong Buy

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