![]() ![]() ![]() The only ethical choice when there is insufficient data is to stop the eIND option entirely and do the phase III - and that is exactly the process that has occurred. On the other hand, if the FDA provided eIND off the phase II but also requested a double-blind phase III "to confirm efficacy" then it becomes an ethical issue to enroll critical patients in that phase III - think of it this way: If the FDA has already made the assumption that this will save lives and can be administered under eIND, but you want critical patients whose life is literally on the line to take a chance that they might be in the placebo arm and die, pretty much everyone and every family member in that position would request the drug under eIND and refuse the chance of getting the placebo. In short, if the FDA allowed leronlimab eIND without a phase III, then effectively the FDA would be saying the data is so strong that a phase III is not even necessary - a pretty unlikely position from the FDA. Once again, your active moderation is appreciated! I believe that transparency is critical and thoughtful negativity is additive to the conversation to the extent it’s actually legitimately thoughtful. Their lies and half truths are annoying at best and harmful/destructive at worst. These folks work exclusively in their own self interest and often at the expense of many honest investors. Unfortunately this has also brought trolls and mal-intentioned shorters. (CYDY) including business summary, industry/sector information, number of employees, business summary, corporate governance, key executives and their. There are serious people here writing serious opinions in an effort to help others and while this may help themselves as well, the drug and company is going to sink or swim on the science, not what longs write on message boards. As a result, the sheer volume of useful information has grown exponentially. Much of this comes from well intentioned investors migrating from other (inferior) message boards. Over the last 30 days there has been an explosion of participation on this subthread. Thanks for aggressively moderating this type of heinous behavior. ![]()
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