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0.3¢ alterity therapeutics limited

What to hopefully look forward too, page-18

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Scottsmyname

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26/08/24

11:14

Post #: 75371818
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Originally posted by RebekahChambers: ↑

My understanding is that you've already listed the benefits. Tax credits, user fee reductions and 7-10 years of market exclusivity. From the FDA website.....

Sponsors seeking orphan drug designation for a drug must submit a request for designation to the agency. Sponsors requesting designation of the same drug for the same rare disease or condition as a previously designated product must submit their own data and information to support their designation request. Orphan drug designation is a separate process from seeking approval or licensing. Drugs for rare diseases go through the same rigorous scientific review process as any other drug for approval or licensing.

So, assuming phase 2 is successful for the -201 trial (as defined by the FDA), then expect phase 3 trials. Years of patient waiting to come with the share price languishing in the doldrums, with the obvious exception of the spike if the data readout in Jan '25 is impressive.

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Agh, thanks for the clarification.

Readouts will be good.

ATH Price at posting: 0.4¢ Sentiment: Buy Disclosure: Held
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