joe, if the FDA did not approve PRR going to the next phase, PRR would be now finished. That is, how important the FDA approval is. PRR has got so far, not because they have filled in a 2300 page submission correctly, but because that they hacve satisfied the FDA that the achievements to date have met all the FDA's requirements. There is still a long way to go, but this was a very important/critical hurdle.
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