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HyGro

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HyGro

Re: biosectinvestor post# 518195

Saturday, 10/01/2022 12:44:29 PM

Saturday, October 01, 2022 12:44:29 PM

Post# of 692882
NWBO specifically called out confounding of naive OS data -- not "what could go wrong" but what DID go wrong.

Regulatory filing is different than APPROVAL. Regulators don't approve post-hoc changes - they wait for applications to review all of the changes to determine their position. NWBO has repeatedly said that they have NOT received approval.
"There can be no assurance that regulatory authorities will allow a product approval to be based upon this approach." That confirms there have been no actual approvals of the protocol and SAP.
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