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Sunday, 12/11/2022 1:46:12 PM

Sunday, December 11, 2022 1:46:12 PM

Post# of 460444
DrMisslings comments about moving forward with approvals:

These are from Dr.M on the CC update of Dec1. It sounds like it is finally "game on".

Setting the stage>>>

At this point we can confirm that all efficacy data, as presented at CTAD, are accurate.


But before I do that, I would like to emphasize that the data is even better than anticipated.


We know from our previous two dementia studies, namely the Anavex 2-73 Alz disease phase 2a,
and phase 2 dementia study in Parkinsons, that we have a strong therapeutic candidate.



Going forward >>>>

We are doing everything in our power to bring this convenient, oral once daily treatment, to patients as soon as feasibly possible.


We plan to meet with regulatory authorities to determine the next steps.


Yes, so we plan to very aggressively now to engage with regulatory authorities
both FDA as well as EMA, UK and pacific Asia
, to aim for interaction aimas scientific advise
conditional marketing authorization, a procedure which is analogous to accelerated approval in the US.
As well as engaging with the scientific medical community, payors, with patient advocacy groups in key
geographies around the world to really aggressively seek the path forward because of the
benefit and unmet need existing for this pathology. Ultimately, it will really be down to the
full data and the discussion with the authorities of how the next stage will play out.
But these are the steps we are doing to be very aggressive.

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