The FDA is done with DViS without trial data or at least the promise to receive it by an absolute deadline this time around.....the problem is that you need a functioning unit in order to create data.....I am not so sure Dean Jane, even with the lawyers, can regain the level of credibility required to persuade the FDA to look at it all over again. Just as shareholders have been strung along, the FDA were also. I really have my doubts....a way too many years have gone by. What Dean Janes is doing is starting all over from the very beginning...no one has the patience anymore.
If the FDA refuses to accept a new application Dean Janes will start dumping shares long before we ever hear about it.
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