years away? share price could go to $1.30 on a near term catalyst. but how bout partnership? approval?
SHARE PRICE RESET - could happen any time
imo like i have said 20 or 25 or 33 times or something... the share price can go, more or less at any time, with the right catalyst.
so no, i'm not saying that a huge share price reset is years away at all
PARTNERSHIP - this year is "possible" but i think next year makes a lot more sense
imo like i have said many times, i wouldn't be shocked by some sort of partnership announced this year, but i definitely don;t EXPECT IT. i just don;t think the data exists and i think partnerships are based on data, not fomo. when there is good enough prospective data on outcomes and durability, then the partnership window officially opens. that data will exist fairly soon, but i think that "good enough prospective data on outcomes and durability" mean that they might need the full N=60 thru 6 months of dosing. that's 4th quarter 2026. and so i don;t think a deal based on that can materialize until 2027.
so no, i;m not saying that a partnership is years away at all. i think its possible within 12 months, if the right data is generated, and that probably has to be the mss data because no other initiatives have a timeline that fits this narrative, yet.
APPROVAL - literally impossible for 2026. highly unlikely for 2027 - would require a CNPV. 2028? certainly possible, via accelerated approval
the requirements take time. and the approval process really doesn't kick off until you have the top line data requirement to support an application.
so yeah, i am still saying that an approval is "years away". and the better the data, the longer it might take. they need to record the DOR to proceed, in my opinion, so all N=60 in the mss trial need the disease to progress first. but if april 2026 enrolled patients haven't progressed after 12 months, then ok, they will cut it off there and prepare an application based on 12 month data.
the absolute shortest path with a CNPV is accelerated approval, with fast track designation, and taking a risk with an application based upon ORR without the DOR. that would potentially enable a database lock by the end of the year. i would be SHOCKED if they achieve that, but technically, it is possible. then 6 months work on a BLA, which would be BLAZING FAST. then 2 months initial review and 6 months substantive review IF they have fast track designation. even that very VERY aggressive pathway bleeds into 2028.
PLEASE, ANYONE, present a timetable for approval, without a CNPV, that achieves an fda approval prior to 2028.
but like i have said, 50 TIMES??? approval doesn't MATTER. the share price can go and go without that.
SHARE PRICE RESET - could happen any time
imo like i have said 20 or 25 or 33 times or something... the share price can go, more or less at any time, with the right catalyst.
so no, i'm not saying that a huge share price reset is years away at all
PARTNERSHIP - this year is "possible" but i think next year makes a lot more sense
imo like i have said many times, i wouldn't be shocked by some sort of partnership announced this year, but i definitely don;t EXPECT IT. i just don;t think the data exists and i think partnerships are based on data, not fomo. when there is good enough prospective data on outcomes and durability, then the partnership window officially opens. that data will exist fairly soon, but i think that "good enough prospective data on outcomes and durability" mean that they might need the full N=60 thru 6 months of dosing. that's 4th quarter 2026. and so i don;t think a deal based on that can materialize until 2027.
so no, i;m not saying that a partnership is years away at all. i think its possible within 12 months, if the right data is generated, and that probably has to be the mss data because no other initiatives have a timeline that fits this narrative, yet.
APPROVAL - literally impossible for 2026. highly unlikely for 2027 - would require a CNPV. 2028? certainly possible, via accelerated approval
the requirements take time. and the approval process really doesn't kick off until you have the top line data requirement to support an application.
so yeah, i am still saying that an approval is "years away". and the better the data, the longer it might take. they need to record the DOR to proceed, in my opinion, so all N=60 in the mss trial need the disease to progress first. but if april 2026 enrolled patients haven't progressed after 12 months, then ok, they will cut it off there and prepare an application based on 12 month data.
the absolute shortest path with a CNPV is accelerated approval, with fast track designation, and taking a risk with an application based upon ORR without the DOR. that would potentially enable a database lock by the end of the year. i would be SHOCKED if they achieve that, but technically, it is possible. then 6 months work on a BLA, which would be BLAZING FAST. then 2 months initial review and 6 months substantive review IF they have fast track designation. even that very VERY aggressive pathway bleeds into 2028.
PLEASE, ANYONE, present a timetable for approval, without a CNPV, that achieves an fda approval prior to 2028.
but like i have said, 50 TIMES??? approval doesn't MATTER. the share price can go and go without that.
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