Thursday, September 27, 2018 8:18:57 AM
I'm joking of course but that's how I see this decrease in share price after presenting strong data, BTD strong, on Monday. Humored, and somewhat awed, by the takedown. JT has already said that each of the 4 cohorts will have their own independent endpoints and that's great to know but maybe he should be more forthcoming in what's going on. For instance, we somewhat accept as BTD for egfr in20in in second or third line treatment as given but what about for Her2. Do you have enough data from the 11 or so patients in 2nd/3rd L HER2 treatment to petition the FDA for BTD using that cohort once they get confirmation on the last several unconfirmed pts ORR (Aside - I can picture the PR "SPPI gets BTG in egfr in20in; we are working on HER2 in20in BTD"? And while he said it in the past, it would be nice to get confirmation that the SPPIs cohort can result in regulatory approval and is that AA or full approval (I'm thinking FA since their is no SoC to compare it to in a P3 study)? And more detail on recruitment in the SPPI study would be fantastic. Telling us recruitment is going well doesn't say anything. It would be nice if he stated when that might happen e.g. "Recruitment is strong and based on current trends we expect the egfr cohort to be fully recruited by approximately the end of the year give or take a month" or something like that would do wonders. Give as much clarity as possible.
And since Oct 2nd is in the 4th Q, wouldn't it be a nice pick me up hearing that the Rolontis BLA was submitted to the agency. That would be a cherry topping on the cake. Anyhows, I'm glad SPPI is going out there to tell their story.
Recent SPPI News
- Form 15-12G - Securities registration termination [Section 12(g)] • Edgar (US Regulatory) • 11/09/2023 10:00:17 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 09/28/2023 04:15:27 AM
- Form S-8 POS - Securities to be offered to employees in employee benefit plans, post-effective amendments • Edgar (US Regulatory) • 09/26/2023 09:23:08 PM
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