RE:RE:RE:Full Video TranscriptEoganacht wrote: Dr. Kulkarni has been involved in this since the beginning of the phase 1b. As principle investigator he knows all of the ins and outs of the data. At this point in the trial it is uncertain whether the FDA is going to exclude the results of the 25 undertreated or not. So what 450 day data should Dr. Kulkarni quote? He cannot exclude the results of the flrst 12 on his own authority and he knows the 450 day data we have right now does not reflect the true efficacy of the treatment.
Why quote a lowball number when he knows that it is likely to change deamatically? He has his reputation to consider and the reputation of the treatment itself. I think he gave the right answer.
"So 54% three month CR, which is quite good, particularly when you look at what has been published to date. We don't have as much long-term data right now, and it is a quite safe and tolerated procedure." plantrader wrote: Any idea why he'd only mention the 90 day CR% ? Probably due to such a small sample size in the longer timeframes? But if it's good enough for a press release, then why not mention the 450 day in the interview? The numbers are what they are. I suppose he's being conservative, doesn't want to put his foot in his mouth if the longer term numbers degrade as the sample size increases. Can't think of another reason he'd choose not to mention it, playing it safe I assume.
I totally agree here Eoganacht. We can see in last NR that the PI ( Dr Kulkarni) had removed the initial 12 patients, but they were included for the NR. So in the end they will most probably be removed for final analysis and hence too early to talk about long term efficacy, and even short term 90 days efficacy will be positively impacted after initial 12 are excluded.
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Latest Interim Analysis of Study II: In Table 1.0 and 2.0, the latest interim clinical data for Study II is presented. Patients, who have been removed from Study II by the PI are included in the analysis; where, their last reported assessment by a PI, prior to removal from Study II, has been carried forward in a Last Observation Carried Forward ("LOCF") analysis. This LOCF analysis reduces the number of patients analyzed in Study II to only Evaluable Patients (Patients who have been assessed by a PI (i.e.: excludes pending assessments))."