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W_W

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Alias Born 07/22/2020

W_W

Re: None

Wednesday, 02/23/2022 4:27:36 PM

Wednesday, February 23, 2022 4:27:36 PM

Post# of 707365
1. Could the TLD be bad?
If it was bad and they hold it for so long, they are begging for lawsuits. Not possible.
2. Why they hold the TLD for so long
After the TLD, next step is to submit BLA. Without volume production facility, they can't submit the BLA or they will fail the FDA approval for sure. So rather than announcing the TLD and waiting for 1 1/2 year to build out the facility, they decided to hold the TLD until facility is completed. Waiting for publication is just an excuse for holding the TLD, publication itself is not a must have for submitting the BLA.
Now the facility is ready, no more show-stopping issues before submitting the BLA, everything else is just icing on the cake, like patents, publication, etc.
They may choose to hold the TLD a little longer so they can maximize its effects.
TLD is any day now.
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