The TRUTH is you don’t know how long the review period will take. I believe the period will be much less than the 180 day period. Every day that slips by more people die. If the regulator staff that reviewed the submission of the manufacturing process are one and the same, it will be a quick process. How many employees of the UK government understand cell therapy and the process of making DCVax-L? Less than 10? More than likely it will be the same doctor that approved the mfg process. Think about it. If it is the same person they are not going to read 1.7 million pages while people continue to die.
I believe you're right, and wrong at the same time. You're right about no named 60 day program, but in the past, the UK has been known to approve new products just after two months. I believe that such an approval is possible here, but it's certainly not guaranteed. Personally I believe it will be second quarter, but perhaps very early in that quarter.
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