Diabetes.......where are we at?, page-8

  1. 17,794 Posts.
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    I suspect the issue may be, that MSB sees mileage in impressing regulators with multiple PhII trials, across multiple disease types [ie, diabetes and RA]......and aiming for lumping all that data in and saying....."can we get some type of breakthrough/early approval please".

    I'm not sure the FDA approves things on the basis of, "They are not just trying one thing; they are trying lots of things, so yeah, in that case we'll give them the green light."


    "but I think RA is just about complete with its PhII now and D is done....so a decision point has been arrived at. "

    I'm not sure what you mean by "D is done".
    Because if it was, a decision would not take so long to make.

    It's going on for 10 months since they published Phase2 trial results.

    That would be long enough a time period over which to negotiate and conclude a partnership, so they must be close to announcing one, other wise as you said, it would be a pity if they dropped the ball on this one...
 
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