I have seen similar apparently early manufacturing announcements e.g. from companies engaged in immune therapies like Car-T cell cancer treatment with complex steps often involving individual patient's own cells in the process.
Don't think I have seen it much for a drug molecule. So agreed there may be a subtle message in this piece of information from Anavex.
Thank you TTT, this is EXACTLY the kind of process insight we need to have: GREAT WORK.
I believe this move indicates that Anavex is actively taking the steps necessary to eventually file for marketing authorization with the EMA. Speculation here, but I believe that if the data is strong, they are planning to take this step after the currently running phase 2 PDD trial. Dr. Missling alluded to this at the ASM, but I believe this to be a tangible indicator of that goal. The new manufacturing information perhaps now adds to this case.
It is also meaningful to me that Ms. Canamaq, the founder of Leon Research, has taken on this role for Anavex. From the article referenced above
Rocio Garcia Canamaq, the founder of Leon Research—Anavex’s CRO for the phase 2 PDD trial in Spain—has been hired to be Anavex’s QPPV as of January per her LinkedIn profile.
I wrote:
No longer excepting applicants: Anyone with access?