NEU 2.88% $16.54 neuren pharmaceuticals limited

FDA Grants Orphan Drug Designation, page-16

  1. 3,284 Posts.
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    I can't paste the link on my phone but if you look at regulatory information on the FDA website for BT designation, I think under point 14 it states that the outcome of a BT Designation will not be disclosed. The applicant will be advised directly by the IND.

    This may explain why you can only find that they have been granted OD status on the internet, but it's possible Neuren have been advised on both outcomes and are waiting for Monday to make an announcement.

    Announcing on a Monday is much better for the SP if it's good news.

    My thinking is they might know both and will have to announce Monday, otherwise they may as well have announced just the one outcome on Friday. They can't hold off for the second outcome without announcing OD to the market now that it's public knowledge.

    Fingers crosses. I may be wrong.
 
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