Enjoy the read! Hehehe.
$Sutro Biopharma (STRO.US)$ Completion of enrollment for Part One of the Phase II/III REFRaME-O1 trial for Luvelta and the anticipation of an update that could affirm its potential, which is estimated to be significantly greater than its competitor, Elahere, in platinum-resistant ovarian cancer (PROC). Bancroft highlights Luvelta’s ability to serve a wider PROC patient base, with the potential to address about 80% of patients expressing folate receptor alpha (FRα), in contrast to Elahere which is limited to approximately 35%.
Additionally, Sutro Biopharma’s strategic expansion of the trial with plans to increase the number of active sites significantly, which could lead to more comprehensive data and a solid foundation for seeking FDA Accelerated Approval. The lack of Elahere’s availability in the EU further strengthens Sutro’s position in capturing a broader patient population. It’s possible that the upcoming interim analysis of the REFRaME-O1 trial might bolster the case for Accelerated Approval based on outcomes such as objective response rate, duration of response, and safety, setting a positive course for full approval that hinges on progression-free survival and overall survival metrics.
Additionally, Sutro Biopharma’s strategic expansion of the trial with plans to increase the number of active sites significantly, which could lead to more comprehensive data and a solid foundation for seeking FDA Accelerated Approval. The lack of Elahere’s availability in the EU further strengthens Sutro’s position in capturing a broader patient population. It’s possible that the upcoming interim analysis of the REFRaME-O1 trial might bolster the case for Accelerated Approval based on outcomes such as objective response rate, duration of response, and safety, setting a positive course for full approval that hinges on progression-free survival and overall survival metrics.
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Trytosaveabit OP amiable Llama_6295 : Yes it is! I sold for like 17% green! And haven’t got back in yet! It’s on my “ update look at your notes “ list! That I was supposed to look at this past weekend! Hehehe. But got busy doing stuff around the house! Hehehe. GL
Arrayfunction : Interesting this news caused so much of a kerfuffle. Getting the participants and starting phase II means they still haven't proved it actually works yet
Trytosaveabit OP Arrayfunction : The early data suggests, so far anyway, that it could end up being the standard for care? But yes if. And it a long way from that. But this is how it moves forward
Arrayfunction Trytosaveabit OP : You are definitely correct there! It's crazy how much of bio-tech is effectively just setting money on fire and hoping for the best!
My thoughts were more around the high risk approach they are taking running phase II/III at the same time. That signals to me either they are extremely confident about the drug based on unreleased efficacy data and want to double-time on getting it to market or the company has decided it is closing its doors regardless of the outcome (so either getting a patent to sell or going bankrupt)
The 2nd one is a lot more likely given the mountain of extra red tape running simultaneously adds - so not going near it as a long investor. But I hope your king of swing style can get some good returns on it!