ATH

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0.4¢ alterity therapeutics limited

Ann: Notice Under Section 708A, page-38

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Scottsmyname

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14/03/24

19:03

Post #: 72892562
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Originally posted by pivalde: ↑

Scottsmyname, yes. ATH is still talking about ph3 and, for sure it may be needed if the phase 2 results are weak or not fully convincing. However, ph 3 is not needed if ph2 results are good when treating an orphan disease. The whole purpose of starting with an orphan disease such as MSA is the possibility of getting to the market without a phase 3 study costing much over the means of a small and poor company such as ATH. Maybe they added the number in the controlled study from 60 to 77 to get more convincing results. That increase had to be made after the early results of the open study, however. To get ATH434 to the market for PD needs a phase 3 study and ATH has no money for that at this time. If FDA approves ATH434 in MSA, it will be much easier to do new studies in new indications and there are many for a moderate iron chelator as ATH434.

Now the company knows quite a lot about the results of the open study but has not told us. They got new investors in February and already at that time they had a lot of patients in the open study, who had taken many months ATH434 and had the blood tests done to demonstrate the possible effect. Is this a sign of efficacy ??? I can not think that they fooled these new investors to get this new money. In the preclinical studies, the effect of ATH434 has been good both in PD and MSA.

I hope we will get good results in the open and placebo-controlled studies, so the company can start planning phase 3 in the PD population and not in MSA.

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Hi pivalde,

Thank you for your reply, much appreciated.

Yeh I never looked into this whole orphan drug phase until the other day which stated orphan drugs do not require a phase 3, so it threw me off reading the voting report.

But afree with your remaining email, fing.ers crossed it goes amazingly well, with stunning results reported in Aprils upcoming conference.

Thank you again.

ATH Price at posting: 0.4¢ Sentiment: Buy Disclosure: Held
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Ann: Notice Under Section 708A, page-38

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Ann: Notice Under Section 708A, page-38

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