RE:RE:RE:Commercialization Timeline Changegebremeskel wrote: Maybe leaving out mention of a partnership was an oversight, but how could we be granted accelerated approval by January 2023? Could there have been a communication from the FDA we haven't heard about yet?
enriquesuave wrote: No partnership,so maybe a Buyout instead? Who knows, or just an oversight?
Eoganacht wrote: In the Sep 2021 Corporate Presentation, on the Phase II Timeline page, commercialization is set to begin in mid-2025 and there is a note - Partner with Big Pharma To Commercialize.
In the Feb 7 2022 Corporate Presentation, on the Phase II Timeline page, commercialization is set to begin in January 2023 (11 months from now) and there is no mention of partnering with big pharma.
What has changed in the last 5 months?
Thanks Eoganacht...I think the latest presentation timeline simply better represents TLT's stance. Their latest projected commercialization timeline is Jan 2023 to Dec 2025. Jan 2023 is oddly fast...even a Big Pharma partner or buyout wouldn't expedite this trial to that degree imo. To me, it may simply mean FDA guidance could be allowing earlier commercialization based on fewer patients treated...so long as the data supports it. Otherwise, the trial would simply be extended (needing 100+ patients) in order to prove its worth to the FDA = projected Dec 2025 timeline. JMO.