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Thank you, Robert. Peter - as I stated, we are currently in Phase 3 so NDA has not been submitted yet. Plan is to list both sites in NDA since we will have manufactured PV lots before NDA submission and will have data from alternate site. ------------------------------ Tom Stothoff Senior Director, ...

We are in Phase 3. Our current API manufacturer has also been doing micronization and we have already made our 3 registration batches of API for the NDA, but their equipment capacity is not ideal for our planned commercial batch size needs so we are in the process of identifying an alternate CMO for ...

I'm not aware of there being a requirement to have a date/version on CTD documents, but I highly recommend adding at least a date to header or footer of each document. To me just a date is suffice. I've worked at companies that include both a date and version/code and some that just use a date. I think ...

For an immediate release oral tablet that used the same bulk granulation to compress 3 different strengths of tablets, we were successful in getting FDA approval for putting one lot up on stability each year (not one lot of each strength) and then rotate the strength from year to year so a batch of each ...

We submitted a Diversity Plan to our IND during Phase 3 and received a response from FDA in 5 months. "...plan appears generally reasonable at this time...The Division continues to develop its approach to the review of diversity plans...and we may provide further feedback as your development plan ...