I agree. It is frustrating. And on the other boards, any conversion like this gets deletes, so many don't know what is going on.
The biggest issue I have is people who are not long bashing the stock. If you are a long, venting frustration, I'm okay with. I feel it counterproductive to post only negatives without explaining why you still are holding the stock, but still I can respect that if you are long. I don't delete those frustrated posts here. But if you have no skin in the game, and are just bashing, posting misleading data, to me that is unethical... something I would never do.
For example, I countered their old 525mg January numbers, with new June numbers just out with the Combo Poster. Also I posted data showing most failures occurred within the first 4 weeks (very likely because the half-life was incorrect). I suspect they noticed all the failures were happening early and thought, maybe the high-life is wrong; that would be my first thought. 525mg is hitting around 70-75%, but after 10 weeks they are 90-95%, without this overlap period. Probably a little as they lose some as people reach 48 weeks. Also, we need to see what the PE is going to be, and if it is based on the maintenance phase or overall, that will be interesting. To me even with many failures early, if they are early and people switch back, it seems much better than just random failures spread thought-out. Maybe the FDA will give focus just on maintenance... I'm not sure. I have searched for other examples, but haven't found much.
Clearly the pivotal trial will focus on fixing those early failures probably by adding the overlap and giving a dose based on the receptor test. They also wanted to do 700mg for everyone for the first 10 weeks and then random after that--I assume to emphasis fixing these early failures with higher dose. But I think the FDA will have them give 525 or 700mg at the start based on the receptor test, with the added 4 week overlap. Both of these should bring that 70-75% number up with 525mg. If the overlap does what I think it will, maybe 80-85% even without the receptor test, then the receptor test will take it home. The FDA likes biomarkers with drugs, the majority of new drugs approved have them I believe I read somewhere, so having a test to determine the dose really helps I feel.
But I'm sure that fine's group gave no explanation or details like that, just focus on the 70% overall and no discussion on the 90%-95% after 10 weeks with explanation of the plans for mono pivotal with the overlap and density test. One snapshot at any given point in time does not give the full picture. Without the full picture, just focused on one aspect, you can miss what is going on.
The biggest issue I have is people who are not long bashing the stock. If you are a long, venting frustration, I'm okay with. I feel it counterproductive to post only negatives without explaining why you still are holding the stock, but still I can respect that if you are long. I don't delete those frustrated posts here. But if you have no skin in the game, and are just bashing, posting misleading data, to me that is unethical... something I would never do.
For example, I countered their old 525mg January numbers, with new June numbers just out with the Combo Poster. Also I posted data showing most failures occurred within the first 4 weeks (very likely because the half-life was incorrect). I suspect they noticed all the failures were happening early and thought, maybe the high-life is wrong; that would be my first thought. 525mg is hitting around 70-75%, but after 10 weeks they are 90-95%, without this overlap period. Probably a little as they lose some as people reach 48 weeks. Also, we need to see what the PE is going to be, and if it is based on the maintenance phase or overall, that will be interesting. To me even with many failures early, if they are early and people switch back, it seems much better than just random failures spread thought-out. Maybe the FDA will give focus just on maintenance... I'm not sure. I have searched for other examples, but haven't found much.
Clearly the pivotal trial will focus on fixing those early failures probably by adding the overlap and giving a dose based on the receptor test. They also wanted to do 700mg for everyone for the first 10 weeks and then random after that--I assume to emphasis fixing these early failures with higher dose. But I think the FDA will have them give 525 or 700mg at the start based on the receptor test, with the added 4 week overlap. Both of these should bring that 70-75% number up with 525mg. If the overlap does what I think it will, maybe 80-85% even without the receptor test, then the receptor test will take it home. The FDA likes biomarkers with drugs, the majority of new drugs approved have them I believe I read somewhere, so having a test to determine the dose really helps I feel.
But I'm sure that fine's group gave no explanation or details like that, just focus on the 70% overall and no discussion on the 90%-95% after 10 weeks with explanation of the plans for mono pivotal with the overlap and density test. One snapshot at any given point in time does not give the full picture. Without the full picture, just focused on one aspect, you can miss what is going on.
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