My notes on Misslings CC this morning:
Rett Excellent in 2nd half of year.
He was grilled pretty good on the change in end points for Rett.
Meeting with the FDA on the Rett adult, and will consult on the Excellent trial. Sounds like he is open to what they suggest, maybe going for approval on the adult and miss the voucher (IMO I think he will wait for the Excellent study to complete and get the voucher since it will be so close in timing).
Will discuss Rett and adult with the FDA around the middle of the year and before Excellent completes.
Does not think addition pediatric studies will be required.
Will move forward for approvals in parallel of not only FDA studies but also other countries where the study was performed.
AD last patient dosed in the middle of the year, and "data released definitely in the 2nd half of the year, and there will be no delay - absolutely".
PD "extended data" is still ongoing will be completed in the next few months .
They are going for 2 separate studies PDD and PD.
"We are currently designing the PDD and the PD studies as we speak" and do not have to wait on the extension data to design the trials, they have all the data they need to do that.
PDD/PD The gut microbiota was measured before and after the trial. It will be measured in the extension part of the trial.
Will be moving forward with Fragile X next, because of the robust data done on animal models. Plus the Fragile X correlates well with the Rett Syndrome.
"We have other indications that we have not mentioned yet." "Right now we want to focus on the indications we have right now."
With 3-71 we be moving forward with Fragile X, schizophrenia, and Alzheimer in Ph-2 studies.
2-41 we are waiting on 2-73 data before moving forward.
10-66 showing reduction in visceral and Neuropathic pain. Currently adding preliminary data to this drug.
"Building up a team for marketing and sales for Rett especially in the US and considering other regions."
Will be to partner for Parkinson and Alzheimer.
"We are already in in midst of execution this expansion" "We are open to partnering international areas like Asia where they cannot reach quickly, or build up quickly".
"We are broadening our scope with additional expertise which helps us moving forward in the direction."
"We have on going partner dissuasions but don't want to expand on that yet because it is premature, and also because it is an advantage to Anavex and shareholders to partner when they have the full data, that when we get the most featured outcome and beneficial out come and the most benefit in a partnership, other than doing it too early."
The moderator did a good job with the questions. I thought this was Missling's best CC to data IMO.
(I may have errors, it is difficult to listen and take notes at the same time, feel free to correct nay misquotes.)
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