more waiting?

The lack of news this month could mean that we have to wait until July for the company to submit responses to the CHMP "List of Questions".

According to the EMA timetable there is no submission date in June (I assume because of summer holidays??). The next submission date is 25/7/2014 so any responses submitted between now and then will actually be recorded as a 25/7 submission.

I say "could mean" because the company may have already submitted responses and simply failed to inform us of the fact.

If, however, we have not yet submitted responses then the earliest date for a positive opinion is now 25/9/2014.

A question for Morpheuz: Did TIS provide any indication that they needed to do a new manufacturing run in order to answer the list of questions??

If so, it occurs to me that this could serve a dual purpose of having a whole batch of fresh stock ready to go upon approval. Although there is the potential that they would have to write off the old stock, at least they would have fresh stock ready to distribute to the customer upon approval.

Rev