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Posted On: 02/19/2022 12:59:43 PM
Post# of 148899
Re: chazzledazzle #118664
Great post… as for the possible BTD for mTNBC. It doesn’t matter to me if it is granted BTD. We have fast track designation already granted and if we file a BLA with the results we have right now without maybe waiting for the March data release or searching down the trial participants. Why waste the extended time to file for the BTD for mTNBC? File the BLA right after the BLA for HIV. As a label extension application for BLA. Preparation of applications take so long. Why wait?
The BTD and the BLA for Fast Tracked is both a 60 day wait for FDA for acceptance and 6 months to approval with an addition confirmation trial.
We could of spent this valuable time with the results we know we already have that will surely get approved and in this calendar year. If we wait to try another BTD it just adds what would be additional time and it could take the same amount of time or longer if not substantially better results again. We should just hire a CRO to fill out the paperwork for the BLA with Dr. Ray overseeing it.
Maybe I am wrong but they are both only 6 months of review before an approval that could tie a another confirmation trial on a fast tracked BLA. Instead of immediate sales with the BTD and another confirmation trial anyway for the BTD.
Either way we have another trial to confirm. The BTD would of been nice with extra help assigned with the FDA helping us fill out the paperwork. That’s a huge help but as the saying goes… time is money…
Unless I am totally wrong and you can not get a Approved jump for phase 2 to BLA approval with Fast Tracked Status and do a confirmation trial as a phase 4 trial. Either way I feel we will have a confirmation trial… so is the wait for another BTD approved status approval worth it? Being that time is money? If we had started this right after the notice they did not authorize a BTD for mTNBC. We would be over half way there and not waiting for any additional information. We had enough to file in our previous application surely. Just my 2 cents worth…
The BTD and the BLA for Fast Tracked is both a 60 day wait for FDA for acceptance and 6 months to approval with an addition confirmation trial.
We could of spent this valuable time with the results we know we already have that will surely get approved and in this calendar year. If we wait to try another BTD it just adds what would be additional time and it could take the same amount of time or longer if not substantially better results again. We should just hire a CRO to fill out the paperwork for the BLA with Dr. Ray overseeing it.
Maybe I am wrong but they are both only 6 months of review before an approval that could tie a another confirmation trial on a fast tracked BLA. Instead of immediate sales with the BTD and another confirmation trial anyway for the BTD.
Either way we have another trial to confirm. The BTD would of been nice with extra help assigned with the FDA helping us fill out the paperwork. That’s a huge help but as the saying goes… time is money…
Unless I am totally wrong and you can not get a Approved jump for phase 2 to BLA approval with Fast Tracked Status and do a confirmation trial as a phase 4 trial. Either way I feel we will have a confirmation trial… so is the wait for another BTD approved status approval worth it? Being that time is money? If we had started this right after the notice they did not authorize a BTD for mTNBC. We would be over half way there and not waiting for any additional information. We had enough to file in our previous application surely. Just my 2 cents worth…
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