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21/09/14
01:07
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Originally posted by jockhock
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Hello all,
I believe we will have an indication earlier than the 24th. The EMA agenda, which should appear sometime Monday afternoon, should indicate if further questions are to be adopted during this months meeting. When questions were raised during the January meeting it appeared as;
EMEA/H/D/002831) (substance to be reviewed) insulin-like growth factor-i (igf-i) segment), (hard-to-heal wounds, primarily venous leg ulcers) • List of Questions: For adoption
In my view, if something similar appears, the clock will again stop at 180 days and we will be again held up. If there is nothing on the agenda I hope we move on to a positive opinion. I'm unsure whether that would happen at this meeting or at the 210 day meeting in October.
Cheers
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Are you sure that we are in the EMA agenda?
EMa has to give an indication if it is favourable or not and nothing more.
I don't think they will discuss it on that meeting but it could be that I'm wrong