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Posted On: 01/06/2022 7:19:19 PM
Post# of 148897
L&G,
We need to keep our perspectives straight for many reasons (one being to better keep our investment in the right side of the fence).
First the facts: We seem to have a drug than can demonstrate in mTNBC median overall survival of 12.1+ months (11.8 for Trodelvy) and 6.2 months in progression free survival (4.8 for Trodelvy) right now with a good possibility of longer times with no serious adverse events . Let me repeat: with no serious adverse events .
So,what is the criteria for BTD ??? According to FDA:
The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.
So, what is a clinically significant endpoint ???
Well, event free survival is one (EPS): Time from randomization* to disease progression, death, or discontinuation of treatment for any reason ( e.g. toxicity, patient preference , or initiation, of a new treatment without documented progression)
https://www.omicsonline.org/open-access/endpo...?aid=70357
What I am trying to say is that a drug with the same overall survival or progression free survival WITHOUT adverse effects should be considered for BTD. This simply because it demonstrates substantial improvement on at least one clinical significant endpoint.
But, of course, we cannot expect the FDA to give us a fair hand (least when GILD is affected). I said it before: I did not trust the FDA to give us BTD. I am not disappointed, but I am happy as our numbers seem to be improving. Apologies in advance to those that believe in a fair and professional FDA. I have lots of questions for them. But I digress.
BTW, GILD paid $21bn for the acquisition of Immunomedics (Trodelvy). As a teaser, if we have an equivalent drug our SP should be $21+ (assuming 1B float).
Ladies & Gents, what we can do in mTNBC is extraordinary , we are prolonging lives of patients with a very difficult-to-treat condition!!! I don’t give a rat’s-ass (forgive my English) is is the same duration as Trodelvy. We will demonstrate longer durations anyway, but without the litany of severe secondary like neutropenia, which is common with sacituzumab and can sometimes be severe and lead to infections that can be life-threatening or cause death.
We need to keep our perspectives straight for many reasons (one being to better keep our investment in the right side of the fence).
First the facts: We seem to have a drug than can demonstrate in mTNBC median overall survival of 12.1+ months (11.8 for Trodelvy) and 6.2 months in progression free survival (4.8 for Trodelvy) right now with a good possibility of longer times with no serious adverse events . Let me repeat: with no serious adverse events .
So,what is the criteria for BTD ??? According to FDA:
The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.
So, what is a clinically significant endpoint ???
Well, event free survival is one (EPS): Time from randomization* to disease progression, death, or discontinuation of treatment for any reason ( e.g. toxicity, patient preference , or initiation, of a new treatment without documented progression)
https://www.omicsonline.org/open-access/endpo...?aid=70357
What I am trying to say is that a drug with the same overall survival or progression free survival WITHOUT adverse effects should be considered for BTD. This simply because it demonstrates substantial improvement on at least one clinical significant endpoint.
But, of course, we cannot expect the FDA to give us a fair hand (least when GILD is affected). I said it before: I did not trust the FDA to give us BTD. I am not disappointed, but I am happy as our numbers seem to be improving. Apologies in advance to those that believe in a fair and professional FDA. I have lots of questions for them. But I digress.
BTW, GILD paid $21bn for the acquisition of Immunomedics (Trodelvy). As a teaser, if we have an equivalent drug our SP should be $21+ (assuming 1B float).
Ladies & Gents, what we can do in mTNBC is extraordinary , we are prolonging lives of patients with a very difficult-to-treat condition!!! I don’t give a rat’s-ass (forgive my English) is is the same duration as Trodelvy. We will demonstrate longer durations anyway, but without the litany of severe secondary like neutropenia, which is common with sacituzumab and can sometimes be severe and lead to infections that can be life-threatening or cause death.
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