Wednesday, November 10, 2021 2:53:49 PM
This is important information from IR if the information transpires as stated:
Here is a copy and paste from alexrenard07 to Anavex's IR on the other board, and the IR reply (which is very encouraging):
This is what I asked:
According to the investors’ presentation on the corporate website there are a number of catalysts listed that investors are told to expect before the end of the calendar year. Is the information listed on the Anavex website accurate in respect to what we should be expecting in relation to:
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. According to the FDA’s timelines for responding to company requests for BTD, Anavex should have received a response but here has been no information shared with investors. Can you please comment on that.
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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. 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.
Here is a copy and paste from alexrenard07 to Anavex's IR on the other board, and the IR reply (which is very encouraging):
This is what I asked:
According to the investors’ presentation on the corporate website there are a number of catalysts listed that investors are told to expect before the end of the calendar year. Is the information listed on the Anavex website accurate in respect to what we should be expecting in relation to:
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. According to the FDA’s timelines for responding to company requests for BTD, Anavex should have received a response but here has been no information shared with investors. Can you please comment on that.
-------------------------------------------------------------
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. 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.
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