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Pinned straw:

Last edited 8 months ago

It will be interesting to see if mass firing of 19%of the FDAs workforce, including the top brass, slows the meetings and information flow down. I suspect yes dramatically and I can’t imagine powerful pharmaceutical companies are going to be happy about potential delays.

With an impending PMS Type C meeting looming we will see if this decision leads to delays for Neu.

https://endpts.com/firings-sweep-across-fda-gutting-leadership-and-whole-offices/?utm_medium=email&utm_campaign=Breaking+Firings+and+resignations+sweep+FDA+Basic&utm_content=Breaking+Firings+and+resignations+sweep+FDA+Basic+CID_f460bae7823a5a6e2b1f82273ed40a1b&utm_source=ENDPOINTS+emails&utm_term=Read+the+full+story

God this chaos is exhausting! I am tired I am going to have a lie down.



mikebrisy
Added 8 months ago

@Nnyck777 yes 19% of the workforce will have a significant impact on approvals capacity, albeit review of NDAs is only one role at the Agency.

The initial impact of the layoffs might be disproportionately high, because the firing process disrupts a team-based process. For example, let's say a team of 8 professionals with different functional skillsets are reviewing a particular NDA file. If one member of that team is fired, then potentially the whole team cannot deliver its milestone output, until that skill is replaced and a new worker gets up to speed. So, it is hard to know where an orphan drug that has not yet review a Priority Review milestone will fare in the work prioritisation that will inevitably be required.

As a shareholder I selfishly hope that the April NNZ-2591 Type C meeting is not affected. If Neuren can be let free to get on with PMS Phase 3, then hopefully by the time they come back in a couple of years the storm of the DOGE chaos might have passed.

So, hoping for the best, but I am bracing myself for an ASX announcement in the next 4 weeks re-setting the timeline, and so I share your unease.

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