Why Im excited!, page-59

"ANP’s partner Strongbridge advised on 19th November 2015 in a corporate update that they were
engaging with regulatory agencies to determine future development plans for COR-004. They also
specified that they were pursuing orphan drug designation for COR-004. ANP are awaiting advice back​

from Strongbridge on their progress and their development plans for COR-004."

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•Request for an Orphan Drug Designation can be submitted at any time during pre-clinical or clinical development, as long as it is submitted prior to submission of the sponsor’s marketing application
–No Investigational New Drug Application (IND) is required
•Typical review cycle is approximately 60-90 days
•Will receive either:
–Designation Letter, OR
–Deficiency Letter
•Once designated, sponsor required to submit annual reports until drug is approved
•Deficiency letter response required within 1 year after issuance
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Coming up to 3 months
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I really wonder WTF they are doing??