(Total Views: 590)
Posted On: 05/11/2020 8:13:16 PM
Post# of 154115
For months share holders were disappointed by CYDY's failure to submit the BLA
as expected. Some made investment decisions based on that expectation. CYDY
did not have the expertise to complete a BLA. NP wisely hired Amerex to complete the BLA. At some point Amerex told NP that the application was complete. Surely, with some relief NP (CYDY) submitted the application completed by Amerex. He gladly announced the submission (completed by Amerex) to the world. Then the FDA moved the goal post. They said the BLA was not complete until they received additional information. Should NP ruin a fine working relationship with Amerex over an unexpected complication. I don't think so. NP's solution is to just fix the problem to satisfy the FDA. Everyone hopes that it is a simple formality. End of story. No big deal unless you want to make one of it.
as expected. Some made investment decisions based on that expectation. CYDY
did not have the expertise to complete a BLA. NP wisely hired Amerex to complete the BLA. At some point Amerex told NP that the application was complete. Surely, with some relief NP (CYDY) submitted the application completed by Amerex. He gladly announced the submission (completed by Amerex) to the world. Then the FDA moved the goal post. They said the BLA was not complete until they received additional information. Should NP ruin a fine working relationship with Amerex over an unexpected complication. I don't think so. NP's solution is to just fix the problem to satisfy the FDA. Everyone hopes that it is a simple formality. End of story. No big deal unless you want to make one of it.
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