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Re: manibiotech post# 544573

Tuesday, 12/06/2022 11:49:00 AM

Tuesday, December 06, 2022 11:49:00 AM

Post# of 699240
We have to come to terms with the fact that there will be no shortcuts on the regulatory side and that the last two years we waited on that journal article have not given us time off the wait to come, especially as no application seems to have been submitted.

This is similar to the realization that sank in after October 5, 2020 that all the time we spent waiting just to get to data lock did not mean the JA would happen faster.

Time burned away at one stage of the process does not buy immunity from extra waiting later.

Hopefully the UK is motivated to move fast and we will see approval there in 2023. If that does not happen, we are (pardon the pun) royally screwed. But I would not necessarily say approval in Q1 2023 is a lock or that we are going to get FDA later in 2023 as I could easily see them dragging things out, especially if the UK makes us wait until Q2 or even Q3 and therefore no pressure builds up on the FDA.

Approval in at least one RA will happen, but shareholders are best served to stop believing a magical shortcut will happen. Things take the regular time with NWBO at best and a longer time at worst and our collective luck does not buy shortcuts.
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