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Wednesday, July 28, 2021 10:30:00 AM
We are currently in mice testing. If that goes well, it'll take about a year for the FDA to approve the Phase 1 trial. Phase 1 will take minimum 2 years to complete. Then another year to approve phase 2. Then another year for those trials. Then Phase 3 will be an additional 3-5 years.
That's how this works. This isn't FUD, this is literally how drugs are brought to market. If you don't know this process, you shouldn't be invested in biotechs. There is no path for Adva to be approved in the next 5 years. None, zip, zilch, nada. It simply cannot happen.
Yes, it may be made available to patients under compassionate use if the safety trials go well. But that doesn't get it to approval quicker, nor does it generate much revenue because under compassionate use the patient must pay out of pocket for the treatment. If insurance isn't covering the drug, it simply isn't worth much yet because not many people can afford it.
If you disagree with me, please let me know the path by which Adva-27a becomes approved for use by any regulatory agency in less than 7 years.
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