Ann: Alterity Granted U.S. FDA Fast Track Designation for ATH434, page-26

Great news, everyone — Fast Track designation is a major milestone!
This marks the beginning of an exciting phase. Many small to mid-sized pharmaceutical companies that have been waiting for FDA feedback now have the clarity they've needed. I wouldn’t be surprised if partnership discussions begin as early as this week, in response to this latest development.

As Dr. Stamler has previously suggested, smaller pharmaceutical firms are likely to move quickly — they simply can't afford to wait or compete directly with larger players. Now that we've secured Fast Track status, I’m optimistic that we won’t need to wait until year-end for potential Accelerated Approval. Dr. Stamler and his team are incredibly thorough and well-prepared — it's clear they're leading the conversation on MSA with the FDA, not just participating in it.

No other company is as advanced in MSA research as Alterity, and that gives us a significant advantage in regulatory discussions and potential market access.

Kyriaco, I completely share your sentiments regarding Dr. Stamler. We’re fortunate to have such a driven and visionary leader at the helm. He’s clearly committed to leaving no stone unturned in the pursuit of success for everyone involved.

GLTAH,

Stockman