Regulatory Open Forum

Dear all,

I am planning for the timelines for PSP and PIP submission and have few questions for people who have gone through this process.

1. The timeline for US PSP and EU PIP says 210 days and 60 or 120 days but I know for PIP it usually takes much longer and can go up to 9-11 months. Can anyone please comment on the review timeline and the agency's response time for PSP? Also, just to confirm, there is nothing like letter of intent for FDA for PSP application?

2. What if the sponsor needs more time than 3 months in the clock stop period for EU PIP? Is 3 months max or is there any flexibility?

3. Similar to EU PIP process for sponsor to have a teleconf if needed after the D60 opinion, does FDA also has option to request a Teleconf after the first 90 day review?

Thanks in advance for your responses. Looking forward to experts to share their experience.

Jas.