Hi jessica211,
It is not wishful thinking. If you refer to page 10 of "Annual General meeting Presentation" dated 30/11/2017, it said the following:
PMA filed 28 Sep 2017
- Granted priority review
- 90% of PMAs without advisory committee reach decision 180 FDA days after filing
- 90% of PMAs with advisory reach decision 320 FDA days after filing.
- Consistent engagement with FDA through Expedited Access Pathway (EAP) has reduced regulatory risk.
We are now into about 260 days since filing and based on the above, I suspect we will hear the decision between July and September. I am actually surprised why it takes so long and we haven't got a decision now, cause of our EAP status and granted priority review??? It is a bit disappointing though.
FDA timing and the summer holidays, page-2
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