Why would you think that it was a something like a fictitious trial not based on the standard of care? Or if we had the ability to change mid stream?
When the trial protocol was approved we were compared to the current standard of care 16 months ago. Then Trodelvy was approved when we were mid trial or actually much later than mid trial. Leronlimab was continued for our trial on what was the standard of care at approved protocol. Met and exceeded standard of care that we needed to. In fact we even exceeded what became the new standard of care that we were not being compared to in our approved protocol.
Cytodyn did what they were suppose to do in the trial and had results that were not only good but were great compared to the standard of care when the trial started. The company completed the trial that was in progress and everyone wonders why would they do that? Should they of not completed the trial? Start over a year later unknowing if they would rewrite a protocol to compare to the new standard of care?
The fact is that Trodelvy was approved when our trial was well over half way of its 12 month trial length. We then continued our trial with the same comparisons to what Trodelvy used in their trial and exceeded their results. Nader did state that we exceeded the new standard of care before sending in the application for BTD but used our protocol and results from our trial protocol in the application just as we were suppose to.
It’s unfortunate that we had a competitor’s approval mid to late in our trial but I am sure it happens with other trials just as well. Comparing both to the previous standard of care was still what the FDA has done and they know we have better results than the current standard of care. Just now BTD better currently until we check to see with another analysis.
What do we do now? Add our last 4 months to our trial and re-apply for BTD? Use our already approved FAST TRACKED BLA for mTNBC and not get the desired help of assigned group of FDA people to help you achieve the full approval. What is the difference in time and what do we lose by applying without the BTD is the question.
Correct me if I am wrong here because I haven’t read the advantages of the BLA over the Fast Tracked application lately but I believe they are both a 6 month to final approval but the difference is the FDA assigns a group of employees to help you to dot your I’s and cross your T’s and help you file all that they require in a properly submitted application. The fast tracked application has to be completed by the company alone and would require a few months in preparation before even starting the clock and then the 6 month clock is started for analysis by the FDA for full approval. Which I am sure we would be eligible for without any doubt. We have huge results…
So if you look at the positives of where we are in future Cancer approval. We could hope for the faster with assigned help from the FDA to still achieve the BTD. Or… we could just go for our fast tracked 6 month vs normal 10 month approval time line of a normal BLA and just prep the Fast Tracked application now and start our clock much earlier than a future possible time set back if we don’t have a analysis to grab more results from our patients from our trial.
Maybe we should be doing both. Having a new CRO working on a Fast Tracked BLA application while we check to see if it is even possible to get the trial results we hope we might have. Time is money and covering both directions is just a good business move in my opinion. I hope Nader and Scott go both directions because you can stop the Fast Tracked BLA if you do get results to reapply for the BTD and the much desired help that a BTD provides.
So if you look at the big picture. Whatever direction we go… we can still have a cancer approval this year with the timelines of a BTD or a Fast Tracked-application if we get on it now and don’t wait to see if we have the needed results from our previous trial.
Either way we are looking at results that are good enough for a BLA approval for Cancer… let’s not forget the end goal of approval and we have these great results and slightly better than the new standard of care. I am super happy that it is going to get us an approval…
It’s not IF… It’s just when now…
This is the bright side of it all… it’s just when!
When the trial protocol was approved we were compared to the current standard of care 16 months ago. Then Trodelvy was approved when we were mid trial or actually much later than mid trial. Leronlimab was continued for our trial on what was the standard of care at approved protocol. Met and exceeded standard of care that we needed to. In fact we even exceeded what became the new standard of care that we were not being compared to in our approved protocol.
Cytodyn did what they were suppose to do in the trial and had results that were not only good but were great compared to the standard of care when the trial started. The company completed the trial that was in progress and everyone wonders why would they do that? Should they of not completed the trial? Start over a year later unknowing if they would rewrite a protocol to compare to the new standard of care?
The fact is that Trodelvy was approved when our trial was well over half way of its 12 month trial length. We then continued our trial with the same comparisons to what Trodelvy used in their trial and exceeded their results. Nader did state that we exceeded the new standard of care before sending in the application for BTD but used our protocol and results from our trial protocol in the application just as we were suppose to.
It’s unfortunate that we had a competitor’s approval mid to late in our trial but I am sure it happens with other trials just as well. Comparing both to the previous standard of care was still what the FDA has done and they know we have better results than the current standard of care. Just now BTD better currently until we check to see with another analysis.
What do we do now? Add our last 4 months to our trial and re-apply for BTD? Use our already approved FAST TRACKED BLA for mTNBC and not get the desired help of assigned group of FDA people to help you achieve the full approval. What is the difference in time and what do we lose by applying without the BTD is the question.
Correct me if I am wrong here because I haven’t read the advantages of the BLA over the Fast Tracked application lately but I believe they are both a 6 month to final approval but the difference is the FDA assigns a group of employees to help you to dot your I’s and cross your T’s and help you file all that they require in a properly submitted application. The fast tracked application has to be completed by the company alone and would require a few months in preparation before even starting the clock and then the 6 month clock is started for analysis by the FDA for full approval. Which I am sure we would be eligible for without any doubt. We have huge results…
So if you look at the positives of where we are in future Cancer approval. We could hope for the faster with assigned help from the FDA to still achieve the BTD. Or… we could just go for our fast tracked 6 month vs normal 10 month approval time line of a normal BLA and just prep the Fast Tracked application now and start our clock much earlier than a future possible time set back if we don’t have a analysis to grab more results from our patients from our trial.
Maybe we should be doing both. Having a new CRO working on a Fast Tracked BLA application while we check to see if it is even possible to get the trial results we hope we might have. Time is money and covering both directions is just a good business move in my opinion. I hope Nader and Scott go both directions because you can stop the Fast Tracked BLA if you do get results to reapply for the BTD and the much desired help that a BTD provides.
So if you look at the big picture. Whatever direction we go… we can still have a cancer approval this year with the timelines of a BTD or a Fast Tracked-application if we get on it now and don’t wait to see if we have the needed results from our previous trial.
Either way we are looking at results that are good enough for a BLA approval for Cancer… let’s not forget the end goal of approval and we have these great results and slightly better than the new standard of care. I am super happy that it is going to get us an approval…
It’s not IF… It’s just when now…
This is the bright side of it all… it’s just when!
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