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The Danish Dude

02/03/22 9:04 AM

#441085 RE: dennisdave #441083

I have an email from David Innes (December of '21) saying that the process is delayed. So that's not opinion, it is fact.



I have a SEC filing from May 2021 saying why the process was delayed. I absolutely believe they were delayed.

As also previously reported, coronavirus-related difficulties have impacted most aspects of the database lock and process ofanalyzing the Phase III trial results, especially with the successive waves of COVID cases in many areas. The independent service firms have had limited capacity, and restrictions on operations. Key experts at certain specialized service providers have been unavailable for periods of time due to illness in their family. Other experts have gone on extended leave due to restrictions on operations. Clinical trial site personnel have been unavailable due to being reassigned for COVID, and the limited site personnel have had to work under restrictions. Committee processes and regulatory processes have been similarly focused on COVID matters and delayed on other matters. Firms such as the ones storing the Phase III trial tissue samples that are needed for certain analyses, and the firms conducting the analyses, continue to have had only limited operations. Even logistical matters such as the shipping of materials have been subjected to substantial restrictions and delays.

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hoffmann6383

02/03/22 9:04 AM

#441086 RE: dennisdave #441083

Post hoc factual basis that you yourself haven't seen. Any holes in this "fact"? If that is your bar, I'd say mine is higher before I consider something as fact.
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lrdpdx77

02/03/22 11:14 AM

#441168 RE: dennisdave #441083

Post the email from DI and let us evaluate what he said. Simple way to prove the point.