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19/11/20
12:50
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Originally posted by Dacca
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Hi Largeraj,
I have often thought about this as well and would like to know where they are at with these further discussions with FDA, that they mentioned would be ongoing to work through the issues that led to it no being approved (I think they stated a 30-60 day timeframe for their subsequent meeting?)?
I understand that they are now focussing on penetration into other countries markets, and I am happy that they are taking that approach; however I feel that there should still be updates about their discussion, and if they have even had that meeting at all?! That seems like price sensitive information to me..!?! Some sort of update, any update; did the meeting occur, was it postponed, did the FDA list the "dangers" they had, to we need to start from scratch or amend our submission.?
I just feel like this has all been forgotten about, and the only reason I can think that they wouldn't update us on this is that the news is bad.. Hoping not, but a simple update would be what us shareholders deserve, whatever the outcome, for better or worse..
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The FDA is looking for evidence of human factor which is the additional information that they requested late December after 8 months of review, hence these commercialisation will be evidence of this.