I agree with most everything you said CTMEDIC…
Post# of 155033
(Total Views: 1188)
Posted On: 03/30/2022 10:09:35 PM
I agree with most everything you said CTMEDIC… but wanted to say Covid may not be an indication we will succeed at. It’s not been high on my expectations list but hoped it could show us greatness. At least at this point. If the DSMB has already reviewed the interim results as stated. Then they didn’t recommend for us to stop the trial and seek EUA like Nader thought with a joined trial Meta-analysis possible. Looks like Covid Critical will be on
its own merit in Brazil now. It would appear we didn’t reach statistical significance enough to apply for EUA to ANVISA in the interim review. Doesn’t mean when we take off our volunteer pause that we still can’t achieve what we need if we have enough patients to get enrolled. So, Jury is out on that indication it would appear until more information is attained from the meeting tomorrow. Maybe we hear tomorrow and it’s good news?
The HIV Combo being paused and patients being moved to another therapy is disturbing to me. Is it Amarex juicing our results in a negative way and turning themselves in essentially to give us a last blow below the knees? Stopping our progress there is not what I wanted to see. I was hoping for a BLA on time and submitted.
On the upside… we have Nash and mTNBC to still cling to and if not BTD’s we have phase 3’s to start. With these two indications still showing great promise we will need to tighten our belt and progress maybe just the mTNBC phase 3 trial. At our current stock price we don’t have a lot of options to trial 3-4 indications at a time and we need to focus on what will time wise bring us to revenue the quickest. That could be a BTD or maybe a phase 3 for mTNBC but either way we need to focus and make this gamble pay off. I am hoping for a BTD with a phase 3 confirmation trial that allows us to start selling Leronlimab for mTNBC as soon as BTD status is granted. I believe if we crush Trodelvy’s results we could take over their 30 million a quarter market and have substantial revenue to continue other trials and other cancers after full BLA approval within 6 months.
There is a few dark horses still that could help us out… like a settlement from mediation or arbitration with Amarex. But as the Lawyers that know the legalities of an issue like this. It could literally be years down the road if we want to crush Amarex. If we offer them something easily settled and we can benefit from a cash infusion then maybe that’s a good choice for our current position… maybe not but on April 4th the 75 page document papers of the audit I believe are suppose to come out or so I have heard. I am not filled in on this. Maybe someone else knows more about this? Maybe this will enlighten us all on our future possibilities with all trial information from Amarex being used or not even worthy enough to be used… which is a scary thought.
We can still hope we still have good enough interim results to apply for a EUA for Covid critical in Brazil? I hope that 4 IV doses is like night and day and we have huge results. This would be the best case scenario and the FDA would have to eat crow and man that would feel good also.
So… it’s not over for us but tomorrow is going to sting a little I am guessing. Some say we are at our bottom. With news like today. We might hit a lower bottom than thought. Maybe the company has a card up their sleeve and if they do… now is the time to pull it out and play it. Let’s hope for the best but brace for the unexpected. Good luck to us all tomorrow
its own merit in Brazil now. It would appear we didn’t reach statistical significance enough to apply for EUA to ANVISA in the interim review. Doesn’t mean when we take off our volunteer pause that we still can’t achieve what we need if we have enough patients to get enrolled. So, Jury is out on that indication it would appear until more information is attained from the meeting tomorrow. Maybe we hear tomorrow and it’s good news?
The HIV Combo being paused and patients being moved to another therapy is disturbing to me. Is it Amarex juicing our results in a negative way and turning themselves in essentially to give us a last blow below the knees? Stopping our progress there is not what I wanted to see. I was hoping for a BLA on time and submitted.
On the upside… we have Nash and mTNBC to still cling to and if not BTD’s we have phase 3’s to start. With these two indications still showing great promise we will need to tighten our belt and progress maybe just the mTNBC phase 3 trial. At our current stock price we don’t have a lot of options to trial 3-4 indications at a time and we need to focus on what will time wise bring us to revenue the quickest. That could be a BTD or maybe a phase 3 for mTNBC but either way we need to focus and make this gamble pay off. I am hoping for a BTD with a phase 3 confirmation trial that allows us to start selling Leronlimab for mTNBC as soon as BTD status is granted. I believe if we crush Trodelvy’s results we could take over their 30 million a quarter market and have substantial revenue to continue other trials and other cancers after full BLA approval within 6 months.
There is a few dark horses still that could help us out… like a settlement from mediation or arbitration with Amarex. But as the Lawyers that know the legalities of an issue like this. It could literally be years down the road if we want to crush Amarex. If we offer them something easily settled and we can benefit from a cash infusion then maybe that’s a good choice for our current position… maybe not but on April 4th the 75 page document papers of the audit I believe are suppose to come out or so I have heard. I am not filled in on this. Maybe someone else knows more about this? Maybe this will enlighten us all on our future possibilities with all trial information from Amarex being used or not even worthy enough to be used… which is a scary thought.
We can still hope we still have good enough interim results to apply for a EUA for Covid critical in Brazil? I hope that 4 IV doses is like night and day and we have huge results. This would be the best case scenario and the FDA would have to eat crow and man that would feel good also.
So… it’s not over for us but tomorrow is going to sting a little I am guessing. Some say we are at our bottom. With news like today. We might hit a lower bottom than thought. Maybe the company has a card up their sleeve and if they do… now is the time to pull it out and play it. Let’s hope for the best but brace for the unexpected. Good luck to us all tomorrow
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