I thought this was relevant in relation to the FDA:
" It is essential that this submission presents sufficient data to enable the FDA to give guidance on the next steps required to lift the PCH and it remains a priority for the Group"
Question here is , has the FDA provided guidance to Prana over the last year? Its quite clear that orphan drug designation should afford the company priority to receive ongoing guidance from the FDA. Here its quite clear they havent been given any guidance to date. So theres seems to be someone in the FDA keen to hold Prana back in my opinion
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