I guess I didn’t research the title “opinyon” but it is still the opinion of one person with no proof.
I have a 5 figure amount of stock and want only for Leronlimab to succeed. The proof of succeeding is in the trials. We show great potential and life saving ability but have not shown 30% efficacy in our primary end point needed for EUA. That’s is a fact. We can whine all day about wanting an approval from the FDA but they just look at us and say... if only you hit the 30% we would bend over backwards giving you the EUA. We can beg for an EUA and say others got approval when they didn’t show the 30% efficacy why can’t we have approval?
These are all valid complaints and heaven knows the pandemic needs us. But the fact is we didn’t hit our numbers YET. That’s a big YET to me. I believe we can and will hit our proper efficacy and strength in another trial. It would be a gift for the FDA to give us a EUA on results that we have shown so far. Believe me when I say I want that gift and I don’t want to wait for another trial. I don’t... but life’s little mysteries don’t always happen the way I want them too.
If we have to wait we have to wait. It’s out of our control is my point. It’s not big Pharma pushing us down. We have to earn our place in statistical evidence and we just have quite got there YET. We will is my opinion. I do hope that internationally we show the world that Leronlimab works and will be approved everywhere. Our FDA might be the last one to approve but they have the right to make us show proof. Hence... no conspiracy...
I have a 5 figure amount of stock and want only for Leronlimab to succeed. The proof of succeeding is in the trials. We show great potential and life saving ability but have not shown 30% efficacy in our primary end point needed for EUA. That’s is a fact. We can whine all day about wanting an approval from the FDA but they just look at us and say... if only you hit the 30% we would bend over backwards giving you the EUA. We can beg for an EUA and say others got approval when they didn’t show the 30% efficacy why can’t we have approval?
These are all valid complaints and heaven knows the pandemic needs us. But the fact is we didn’t hit our numbers YET. That’s a big YET to me. I believe we can and will hit our proper efficacy and strength in another trial. It would be a gift for the FDA to give us a EUA on results that we have shown so far. Believe me when I say I want that gift and I don’t want to wait for another trial. I don’t... but life’s little mysteries don’t always happen the way I want them too.
If we have to wait we have to wait. It’s out of our control is my point. It’s not big Pharma pushing us down. We have to earn our place in statistical evidence and we just have quite got there YET. We will is my opinion. I do hope that internationally we show the world that Leronlimab works and will be approved everywhere. Our FDA might be the last one to approve but they have the right to make us show proof. Hence... no conspiracy...
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