Here are some interesting events, with timelines to remember for 2015.
1. Filing of the NDA in the first quarter of 2015.
2. 60 days for the FDA to accept the application.
3. Upon potential acceptance, FDA could also grant priority review.
4. With priority review, six months PDUFA date, without, 10 months.
5. Sleep disturbance trial for PDP patients first half of 2015.
6. EU filing 6- 9 months post FDA filing, so around 3rd quarter.
7. Potential top line ADP in fourth quarter of 2015 or around end of 2015.
8. Schizophrenia maintenance trial to commence 2nd half of 2015.
9. More information on Pima for Autism 2015.
1. Filing of the NDA in the first quarter of 2015.
2. 60 days for the FDA to accept the application.
3. Upon potential acceptance, FDA could also grant priority review.
4. With priority review, six months PDUFA date, without, 10 months.
5. Sleep disturbance trial for PDP patients first half of 2015.
6. EU filing 6- 9 months post FDA filing, so around 3rd quarter.
7. Potential top line ADP in fourth quarter of 2015 or around end of 2015.
8. Schizophrenia maintenance trial to commence 2nd half of 2015.
9. More information on Pima for Autism 2015.
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