RE:Becoming a commercial-stage pharmaceutical company We officially first heard about "Commercialization phase" in the Feb. 7 2022 corporate presentation. They had probably been hinted by the FDA that, if things continued to be in line with that, despite the issue of the first 12 patients, that FDA Breakthrough designation was really a high probability given that in August 2021, Ph. 1B p#5-6 had been cancer free with a single dose for 3y.
Then, we had to reach that p#25 450-days milestone late 2022 in order to be able to apply for Breakthrough designation.
We're now awaiting this pivotal FDA decision within-3 months.
We have everything to be hopeful. Especially under 0.35$ avg for any of us.
________________
ScienceFirst - (5/25/2023 8:41:19 AM)
Becoming a commercial-stage pharmaceutical company
That's the exact wording and clear distinction the industry makes when a biotech, that has no revenues because still focused on R&D, moves to higher notch and is about to generate revenues.
From a R&D biotech to becoming a commercial-stage pharmaceutical company
The next few months will look very interesting both in terms of fundamentals and valuation.