Quote: Someone posted that "common sense" suggests that EUA would make enrolling patients in CD16 & CD17 impossible. Who would risk getting placebo.
I am pretty sure a conformational trial does not have to use placebo. They have other ways to compare an average mortality from an average of other trials.
When you look at today’s headline in the PR. Does it make sense to think that EUA is on the cusp? Saying the non-dilutive financing is for manufacturing is a big deal. There was many ways to present this financing. But only for manufacturing??? That is a hammer title of that PR. It is telling me we didn’t need this financing for helping with our trial. All though some might be used for that. It really is just saying we need a whole bunch more than our 1.2 million doses we currently have. This is excellent news and shows without saying what is happening with the FDA in my opinion.
All though the first few sales will really fund our need for manufacturing. $25 million will only fund 350,000 or less doses. Or is it just the down payment for a larger order? If we sell the 1.2 million doses it is worth around $2 billion. That will be our cash needed for manufacturing cash to flow to buy any needed doses as we complete sales agreements across the world.
Maybe I am reading to much into the financing headline. I don’t think I am though... I feel it is a perfect match to where we are with talks with the FDA and all the changes that have happened to the trials and nothing solid in a protocol. Cytodyn has been throwing everything at the wall and hoping it would stick and the last finding of 82% at 14 days improved mortality must of been a home run and changed everything the way the FDA viewed the trial. Because the other two trials were designed then tossed for a 4 dose trial. The half life must of been recognized as the issue and now the FDA is a believer. Could it be? Is this what is happening behind closed doors? Will tomorrow be an announcement of EUA? I want to believe that. It sounds entirely possible. It’s a puzzle and when you look at all the pieces. It says something is happening now not later. Could be a good day tomorrow... we will see...
Read More: https://investorshangout.com/post/newpost/605...z6rAES2SQg
I am pretty sure a conformational trial does not have to use placebo. They have other ways to compare an average mortality from an average of other trials.
When you look at today’s headline in the PR. Does it make sense to think that EUA is on the cusp? Saying the non-dilutive financing is for manufacturing is a big deal. There was many ways to present this financing. But only for manufacturing??? That is a hammer title of that PR. It is telling me we didn’t need this financing for helping with our trial. All though some might be used for that. It really is just saying we need a whole bunch more than our 1.2 million doses we currently have. This is excellent news and shows without saying what is happening with the FDA in my opinion.
All though the first few sales will really fund our need for manufacturing. $25 million will only fund 350,000 or less doses. Or is it just the down payment for a larger order? If we sell the 1.2 million doses it is worth around $2 billion. That will be our cash needed for manufacturing cash to flow to buy any needed doses as we complete sales agreements across the world.
Maybe I am reading to much into the financing headline. I don’t think I am though... I feel it is a perfect match to where we are with talks with the FDA and all the changes that have happened to the trials and nothing solid in a protocol. Cytodyn has been throwing everything at the wall and hoping it would stick and the last finding of 82% at 14 days improved mortality must of been a home run and changed everything the way the FDA viewed the trial. Because the other two trials were designed then tossed for a 4 dose trial. The half life must of been recognized as the issue and now the FDA is a believer. Could it be? Is this what is happening behind closed doors? Will tomorrow be an announcement of EUA? I want to believe that. It sounds entirely possible. It’s a puzzle and when you look at all the pieces. It says something is happening now not later. Could be a good day tomorrow... we will see...
Read More: https://investorshangout.com/post/newpost/605...z6rAES2SQg
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