“Would love to hear any results they can give on
Post# of 154032
(Total Views: 459)
Posted On: 01/06/2021 11:36:09 AM
Re: LaundryMoney #71460
“Would love to hear any results they can give on cancer since I see the BTD mention on the agenda.”
The last time that NP mentioned mTNBC cancer trial enrollment (October?), BTD for cancer still seemed 6+ months or more away. For BTD, the FDA wants to see an improvement in over available therapies in a clinically significant endpoint, which in this case would be PFS. That would take CYDY time and patients to show an increase in PFS. Now, one could argue that a decrease in CTCs and/or CAMLs could meet BTD criteria as an effect on a bio marker that suggests the potential for a clinically meaningful effect on the underlying disease is also acceptable.. Safety can also be part of the reason to grant a BTD, as long as there’s also an improvement in a clinically significant endpoint.
Hopefully NP provides an enrollment update for both cancer trials, which will give us a good idea of when a BTD could be submitted. My hope is that CYDY waits for a solid number of patients (30+) demonstrate clear BTD criteria before submitting so CYDY doesn’t get another BTD rejected due not to lack of efficacy, but just a poor application.
The last time that NP mentioned mTNBC cancer trial enrollment (October?), BTD for cancer still seemed 6+ months or more away. For BTD, the FDA wants to see an improvement in over available therapies in a clinically significant endpoint, which in this case would be PFS. That would take CYDY time and patients to show an increase in PFS. Now, one could argue that a decrease in CTCs and/or CAMLs could meet BTD criteria as an effect on a bio marker that suggests the potential for a clinically meaningful effect on the underlying disease is also acceptable.. Safety can also be part of the reason to grant a BTD, as long as there’s also an improvement in a clinically significant endpoint.
Hopefully NP provides an enrollment update for both cancer trials, which will give us a good idea of when a BTD could be submitted. My hope is that CYDY waits for a solid number of patients (30+) demonstrate clear BTD criteria before submitting so CYDY doesn’t get another BTD rejected due not to lack of efficacy, but just a poor application.
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