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pSivida Corp. Message Board

  • mickmack50 mickmack50 Jun 21, 2013 11:07 AM Flag

    Can Tethadur get "Breakthrough" designation?

    Hernando, You do bring up great points as they relate to new PSDV pipeline hurdles and the timeframe that might be associated with eventual product approval. However, I believe Tethadur will be a platform that fits perfectly into this new FDA category. The FDA does love the class of new protein drugs such as Eylea and Lucentis. PSDV's biosilicon has already been proven to be well tolerated in the pancreatic trials through pII of brachysil. Preclinical trials in the tech agreements must be making progress to stimulate big pharma interest. It is my belief that we about to see how a well tolerated platform ( biosilicon) will be seen as a major breakthrough by the FDA, thus reducing the timeframe bringing sustained release of these critical drugs to market. With this in mind the inevitable connection between ALIM and PSDV becomes lessened, and rightly so. Paul Ashton's reference to the successful delivery of these drugs is not to be taken lightly, as there are so few technologies currently available.

 
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