EMA Fails to Follow Legislation and Its Own Policy, page-7

Hi Cro,

No I haven't forgotten. Obviously you are suggesting that the application for an extension of time to submit answers and the latest announcement that the submission date will be delayed until January are one and the same thing. That did cross my mind but for that to be true it would mean that yesterday's public announcement contained deliberate lies by the company to the market. I would think that would be a very stupid thing to do so I don't believe it to be the case.

One possible scenario is that TIS was given a time frame to answer the outstanding issues. They couldn't make that time frame and asked for an extension. CHMP granted their extension but then said that your extension creates extra work for us at a time we don't want any so we'll stop you from submitting for 3 months at which time it suits us.

Rev