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Posted On: 06/22/2021 9:49:21 AM
Post# of 36519
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Hylander,
Great job on extracting those positive nuggets from the 10-Q. I’d like to add another from the 10-Q:
The following table summarizes our research and development projects in development and the next milestone in its development and estimated costs to achieve such milestone:
List of Projects
Company (Subsidiary) R&D Project Current Milestone Target Estimated Milestone Start Dates Estimated Milestone Costs
NGIO AE37 Cancer Vaccine Phase II Clinical Trial January 2022 1,800,000
NGIO COVID-19 Vaccine Development of Human Trials September 2021 1,700,000
Regentys ECM First In-Human Clinical Trial in Australia December 2022 2,000,000
NGDx Express I & II FDA 510K Approval 750,000
So, the IND needs approval in July in order for the human trials to start in September. The question is the projected timetable of the Phases.
https://www.fda.gov/patients/drug-development...l-research
After reviewing all the IND steps, no wonder why it has taken so long to get here when you don’t have the resources of a large company with a hundred detail oriented employees at your fingertips to do all the necessary “grunt” work.
Great job on extracting those positive nuggets from the 10-Q. I’d like to add another from the 10-Q:
The following table summarizes our research and development projects in development and the next milestone in its development and estimated costs to achieve such milestone:
List of Projects
Company (Subsidiary) R&D Project Current Milestone Target Estimated Milestone Start Dates Estimated Milestone Costs
NGIO AE37 Cancer Vaccine Phase II Clinical Trial January 2022 1,800,000
NGIO COVID-19 Vaccine Development of Human Trials September 2021 1,700,000
Regentys ECM First In-Human Clinical Trial in Australia December 2022 2,000,000
NGDx Express I & II FDA 510K Approval 750,000
So, the IND needs approval in July in order for the human trials to start in September. The question is the projected timetable of the Phases.
https://www.fda.gov/patients/drug-development...l-research
After reviewing all the IND steps, no wonder why it has taken so long to get here when you don’t have the resources of a large company with a hundred detail oriented employees at your fingertips to do all the necessary “grunt” work.
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