I am pleased to say that as of today we do expect the catalysts you mentioned in your email to be attained accordingly. Please note, as is the case with all future expectations, it must be noted that we do not control the future and therefore plans and expectations may change.... if and when this were to occur we would make public such information in accordance with Regulation FD.
With respect to dialogue with FDA regarding Rett Syndrome - We can not comment on current or potential dialogue in a private manner, such as this email. This type of information (disclosure of communications with the FDA) must be done via press release and/or 8K filing. At this time we have no comment but we do understand the eagerness on behalf of investors and medical community for us to disclose at the earliest possible time information and progress with the FDA.
Agree it is an encouraging reply. Thanks for asking/posting. Use Caution but it is open about the next/near future. We are at least on the same page w/ IR.
Thanks Red, for working to get this encouraging info! 1. Top Line AVATAR 2. Top Line Phase 1 Anavex 3-71 3. Initiation of Phase 2/3 Fragile X 4. Initiation of Phase 2/3 Clinical Trial for new rare disease
Also, Missling has implied earlier in the year that Anavex would be engaging in dialogue with the FDA regarding fast track approval and break through designation of 2-73 to treat Rett Syndrome.
From IR today:
I am pleased to say that as of today we do expect the catalysts you mentioned in your email to be attained accordingly. expectations may change.... if and when this were to occur we would make public such information in accordance with Regulation FD.
With respect to dialogue with FDA regarding Rett Syndrome - We can not comment on current or potential dialogue in a private manner, such as this email. ... we do understand the eagerness on behalf of investors and medical community for us to disclose at the earliest possible time information and progress with the FDA.