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Posted On: 12/22/2020 12:42:08 PM
Post# of 36564
Since we’re not getting news updates or a 2020 annual meeting, I ferreted out some info from the 10-Q that I view as encouraging.
On November 17, 2020, Generex signed statement of work (SOW) #2 with CTL to conduct FDA requested laboratory testing and analysis for a contracted amount of $82,780.
On November 19, 2020 Generex signed a work order with Polypeptide Laboratories to manufacture GMP grade Ii-Key vaccines for the COVID-19 vaccine program for a contracted amount of $273,000.
On November 25, 2020 Generex signed a work order with Covance to conduct preclinical animal immunogenicity studies for the Ii-Key COVID-19 vaccine program. The cost of the project is projected at $130,135.
On December 7, 2020, Generex signed a contract with Patheon, by Thermo Fisher Scientific, to provide manufacturing and fill/finish services for the clinical supply of aseptically filled Ii-Key-SARS COV2 Vaccine Sterile Liquid Vials (the “Product”) for a Phase I/II study. The cost of the project, specifications for which are still in development, are expected to be in the range of $1,127,000 and $1,530,000.
SPIN: You don’t sign contracts for services you don’t need. You are still obligated to pay the contracted amount.
Next year’s projects/goals:
Company (Subsidiary) R&D Project Current Milestone Target Estimated Milestone Start Dates Estimated Milestone Costs
NGIO AE37 Cancer Vaccine Phase II Clinical Trial March 2021 $1,800,000
NGIO COVID-19 Vaccine Development of Human Trials Jan. 2021 1,700,000
Regentys ECM First In-Human Clinical Trial in Australia June 2021 2,000,000
NGDx Express I & II FDA 510K Approval Feb. 2021 750,000
SPIN: The cost of these projects are within a reasonable GNBT affordability.
I think our trip with GNBT/NGIO is now traveling thru a dead (no cell reception) zone. Perhaps in January, if we get a start on human trials coupled with an IPO date/price, we can put 2020 behind us and look at 2021 as a much brighter future.
On November 17, 2020, Generex signed statement of work (SOW) #2 with CTL to conduct FDA requested laboratory testing and analysis for a contracted amount of $82,780.
On November 19, 2020 Generex signed a work order with Polypeptide Laboratories to manufacture GMP grade Ii-Key vaccines for the COVID-19 vaccine program for a contracted amount of $273,000.
On November 25, 2020 Generex signed a work order with Covance to conduct preclinical animal immunogenicity studies for the Ii-Key COVID-19 vaccine program. The cost of the project is projected at $130,135.
On December 7, 2020, Generex signed a contract with Patheon, by Thermo Fisher Scientific, to provide manufacturing and fill/finish services for the clinical supply of aseptically filled Ii-Key-SARS COV2 Vaccine Sterile Liquid Vials (the “Product”) for a Phase I/II study. The cost of the project, specifications for which are still in development, are expected to be in the range of $1,127,000 and $1,530,000.
SPIN: You don’t sign contracts for services you don’t need. You are still obligated to pay the contracted amount.
Next year’s projects/goals:
Company (Subsidiary) R&D Project Current Milestone Target Estimated Milestone Start Dates Estimated Milestone Costs
NGIO AE37 Cancer Vaccine Phase II Clinical Trial March 2021 $1,800,000
NGIO COVID-19 Vaccine Development of Human Trials Jan. 2021 1,700,000
Regentys ECM First In-Human Clinical Trial in Australia June 2021 2,000,000
NGDx Express I & II FDA 510K Approval Feb. 2021 750,000
SPIN: The cost of these projects are within a reasonable GNBT affordability.
I think our trip with GNBT/NGIO is now traveling thru a dead (no cell reception) zone. Perhaps in January, if we get a start on human trials coupled with an IPO date/price, we can put 2020 behind us and look at 2021 as a much brighter future.
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