Hi
I did attend the AGM can add to your questions.
Yes, only 65% of the questions have been answered though it appears that was actually 100% of the questions due at that time. When the original questions were asked at the 120 day mark some answers were due at 180 days (the ones that we were aware of) and some could wait until after CE was granted. What happened at the last meeting of the EMA was that those questions that were not due until later were brought forward and now must be answered before CE Mark is granted.
As the questions had been asked, and the company knew that they had to be answered at some point, they had started work on them which is continuing.
BTW the original submission in response to the questions ran to 8,500 pages so they are not "light" questions.
Your second question relates to the Expiry Date on the product. The product has expired. However, the product is frozen and testing is undertaken every quarter and testing has shown that there has been no (NIL) reduction in efficacy so it can all be re-dated when CE Mark comes through. The CEO did explain the process for re-dating and it is no biggie.
Hope that this helps
Scott
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