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Posted On: 04/04/2022 3:22:17 PM
Post# of 148903
Re: craigakess #121511
Craig… how could you be more wrong? A scratch off lottery ticket? Really?
Just HIV Combo and mTNBC shows you that trials have proved by the science that we will have future approvals. It’s not a matter of if… it’s a matter of when.
The only real dispute is when… HIV Combo is a minimum of 9 months if we were to file in May. So next year for a BLA. But that’s best case scenario.
As for mTNBC… we have another phase 3 trial coming now with a phase two that was equal to or slightly better than Trodelvy as the standard of care. This also is not a IF… but a when. The issue with that… is it could be next year also since we missed the boat on the BTD per SK.
So don’t give us a lottery presumptive prediction when it’s not a matter of IF. As long as we keep our funding going we will get there. This much is almost guaranteed by real results. Tell me I am wrong… tell me these two indications won’t prove out and why they won’t. Of coarse there is a properly filled out BLA that needs to happen. Do you think we will hire another rogue CRO that doesn’t have the experience we need? I don’t think so…
We haven’t even mentioned Nash and that could still get a BTD or if not we continue on in a phase 3 trial in what is expected to have great results to prove our drug too.
At any point we could get lucky and find another partner besides Vyera/Regnum to help us get over the finish line. I am not a big believer of this but the CC said we are in NDA’s and anything is possible.
All I know is our class of employees of Cytodyn has improved dramatically since I have been invested. We have had an improvement by leaps and bounds in our BOD. Our scientific board represents almost all our pending indications we are looking at and mostly PHD’s in each indication. We are building a machine if you take a step back and look at where we are… compared to where we were just 2 or even 3 years ago. Things change as time goes on and we have really upped our game all around. So… tell me why we are a lottery ticket at best again…
Just HIV Combo and mTNBC shows you that trials have proved by the science that we will have future approvals. It’s not a matter of if… it’s a matter of when.
The only real dispute is when… HIV Combo is a minimum of 9 months if we were to file in May. So next year for a BLA. But that’s best case scenario.
As for mTNBC… we have another phase 3 trial coming now with a phase two that was equal to or slightly better than Trodelvy as the standard of care. This also is not a IF… but a when. The issue with that… is it could be next year also since we missed the boat on the BTD per SK.
So don’t give us a lottery presumptive prediction when it’s not a matter of IF. As long as we keep our funding going we will get there. This much is almost guaranteed by real results. Tell me I am wrong… tell me these two indications won’t prove out and why they won’t. Of coarse there is a properly filled out BLA that needs to happen. Do you think we will hire another rogue CRO that doesn’t have the experience we need? I don’t think so…
We haven’t even mentioned Nash and that could still get a BTD or if not we continue on in a phase 3 trial in what is expected to have great results to prove our drug too.
At any point we could get lucky and find another partner besides Vyera/Regnum to help us get over the finish line. I am not a big believer of this but the CC said we are in NDA’s and anything is possible.
All I know is our class of employees of Cytodyn has improved dramatically since I have been invested. We have had an improvement by leaps and bounds in our BOD. Our scientific board represents almost all our pending indications we are looking at and mostly PHD’s in each indication. We are building a machine if you take a step back and look at where we are… compared to where we were just 2 or even 3 years ago. Things change as time goes on and we have really upped our game all around. So… tell me why we are a lottery ticket at best again…
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