“- Cancer BTD - GvHD BTD” The submissio
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Posted On: 10/23/2020 3:54:47 PM
“- Cancer BTD
- GvHD BTD”
The submission of a BTD for Cancer of GvHD is 6 or more moths away, if not longer. The mTNBC trial had 2 patients enrolled at the time of the ASM. Given the way the trial is designed, the first patients start on the lowest dose (350mg). We know from the basket trial that the lowest dose hasn’t been effective, according to comments by NP and Dr. Jay. 6 patients have to be enrolled at the 350mg dose, 6 at the 525mg dose and then 6 patients at the 700mg dose. NP said that in order to file a cancer BTD, they need a minimum of 5 patients on the 700mg dose (the most effective dose) for 6 months. We need 10 more patients enrolled to fill the 350mg and 525mg dosing before we can even get to 700mg patients. Basically, there’s a considerable amount of time remaining until an mYNbC BTD is filed and IMO, 5 patients won’t cut it. We did research awhile ago and 40-50 patients was the smallest cancer trial that BTD had been awarded to. The basket trial is still pending a dosage change to 700mg per Dr, Jay and has yet to happen according to clinicaltrials.gov.
GvHD? I won’t even bother making a comment here. This trial has been restarted and stopped so many times. One patient was enrolled back in FEB2020 and we were never given an update on that patient, which tells me that patient didn’t respond
Cancer and GvHD are perpetual topics that NP uses as part of his sales pitch and will not have an impact on the SP until at least late 2021.
- GvHD BTD”
The submission of a BTD for Cancer of GvHD is 6 or more moths away, if not longer. The mTNBC trial had 2 patients enrolled at the time of the ASM. Given the way the trial is designed, the first patients start on the lowest dose (350mg). We know from the basket trial that the lowest dose hasn’t been effective, according to comments by NP and Dr. Jay. 6 patients have to be enrolled at the 350mg dose, 6 at the 525mg dose and then 6 patients at the 700mg dose. NP said that in order to file a cancer BTD, they need a minimum of 5 patients on the 700mg dose (the most effective dose) for 6 months. We need 10 more patients enrolled to fill the 350mg and 525mg dosing before we can even get to 700mg patients. Basically, there’s a considerable amount of time remaining until an mYNbC BTD is filed and IMO, 5 patients won’t cut it. We did research awhile ago and 40-50 patients was the smallest cancer trial that BTD had been awarded to. The basket trial is still pending a dosage change to 700mg per Dr, Jay and has yet to happen according to clinicaltrials.gov.
GvHD? I won’t even bother making a comment here. This trial has been restarted and stopped so many times. One patient was enrolled back in FEB2020 and we were never given an update on that patient, which tells me that patient didn’t respond
Cancer and GvHD are perpetual topics that NP uses as part of his sales pitch and will not have an impact on the SP until at least late 2021.
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