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Re: erg61 post# 789510

Tuesday, 09/23/2025 2:50:39 PM

Tuesday, September 23, 2025 2:50:39 PM

Post# of 828958

Could someone so kindly explain what possibly could be the hold-up on approval?



According tho the MHRA there is no backlog....I take this to mean we are in a RFI and the RFI is taking long to answer could be for the following reasons:

1). The questions/requests are very difficult to come by (hopefully not impossible).
2). The Consultants needed to answer the questions/requests are out on vacation (similar to what happen during the delayed submission).
3). The application was amended and to include all cancers and or flashworks (and the delay is due awaiting for automation to be approved).
4). The application was shitcanned and reapplied with combo options (where is the PR?).

Low probability on all the items except for item #1.
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