Saturday, April 16, 2022 12:09:11 AM
Thanks hmuney! There certainly is a lot of chatter being drum up over the next month and a half. One could say LL went dark for a while there but she sure doesn’t seem to be restraining herself now.
And Marnix in a promotional theater again…that sure doesn’t look like June is in the Quiet Period and possibly not May either.
Back when I was pushing my Premarket Promotion stance, a friend asked me to lock in a date and I told him April 29.
Again, for those who love to poke fun at me and the tote bag… my most recent input on the Coming Soon reg was that the 6 month rule only applies to path 2, actually saying “Coming Soon DCVax(R)-L”. The first path requires the same authorization from FDA, but it is not time bound. You see, FDA, is pretty uptight about making False or Misleading statements so the rule defines how long “soon” is. In both cases, FDA has already agreed to approval but hasn’t finished the review and label language agreement.
“Coming Soon the $10+ Million Man, Dendream” and his millionaire family and friends, many friends.
And Marnix in a promotional theater again…that sure doesn’t look like June is in the Quiet Period and possibly not May either.
Back when I was pushing my Premarket Promotion stance, a friend asked me to lock in a date and I told him April 29.
Again, for those who love to poke fun at me and the tote bag… my most recent input on the Coming Soon reg was that the 6 month rule only applies to path 2, actually saying “Coming Soon DCVax(R)-L”. The first path requires the same authorization from FDA, but it is not time bound. You see, FDA, is pretty uptight about making False or Misleading statements so the rule defines how long “soon” is. In both cases, FDA has already agreed to approval but hasn’t finished the review and label language agreement.
“Coming Soon the $10+ Million Man, Dendream” and his millionaire family and friends, many friends.
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