News Focus
News Focus
icon url

kund

06/25/24 2:10 PM

#462422 RE: Reyeton #462421

Everything is a figure of speech for this CEO: "soon," "very soon," "around the corner," "hope you are excited," "data-rich quarter," "H1," "H2," "next quarter"....
icon url

williamssc

06/25/24 2:19 PM

#462424 RE: Reyeton #462421

Can you point to which webcast Missling reportedly said 1 million pages? I never heard him say 1 million pages but it has been bandied about this forum ad nauseam. Thanks
icon url

Steady_T

06/25/24 4:22 PM

#462433 RE: Reyeton #462421

NWBO has said that their submission to the UK was 1.7 million pages. That is an extreme case since they are reporting multiple trials over a 15 year period. Also they are filing on a new method for culturing cells.

Anavex's submission will be much shorter since the manufacturing process is pretty standard and they have a lot less data to report. As of 2016 the average NDA was about 100,000 pages. Other sources indicate that submissions are estimated at 500,000 pages.

Since 2-73 has a novel method of action (MOA) it is likely that there will be a lot of material devoted to explaining that novel MOA. Also the support for the various bio markers will likely increase the size of the submission.

So, the Anavex NDA could very well be quite large.