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Re: None

Tuesday, 12/13/2022 5:54:58 PM

Tuesday, December 13, 2022 5:54:58 PM

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Fast Track designation can be requested with nonclinical data and/or preliminary clinical evidence.


they will request a fast track status.

and they have 2 phases of clinical trials done.

drug is safe and effective. critically needed.
100% disease control.

zero side effects.

so they do not need phase 3 clinical trials.

company is also siting on a ton of cash.

this stock can hit $20 in a matter of just a few days.

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In the Phase 2 ACE-Breast-03 study, which took place in the U.S., Korea, and Australia, the drug was assessed as a treatment for HER2-positive mBC (metastatic breast cancer) patients who are resistant or refractory to T-DM1.

The preliminary results showed a 51.7% overall response rate (ORR) and 100% disease control rate (DCR) following treatment with ARX788. Additionally, no drug-related serious adverse events (SAEs) were noted by any patients.

With investors reacting the way they did, it’s safe to say they were impressed with the results; considering how big the breast cancer market is, the drug’s potential has caused a bit of a stir.
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