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Just to clarify, i emailed this question to DVRG and was told by GB they are working with both companies. They can be used as binding agents on the MicrotoxPD chips that capture the dangerous pathogens, such as SARS-CoV-2 and many other biomarkers.
We work with both companies.
@bella
I had email reply on this question and was told still working with both companies.
Thanks for taking the time Gerry.
Don`t know if posted before but interesting read.
https://www.fda.gov/drugs/news-events-human-drugs/generic-drug-approval-process
Been having a read up on FDA web site and it seems AML should qualify for Breakthrough therapy designation or one of the other fast track routes going by their criteria in m/o.
for AML hemo car-t, an acute form of leukemia for which there is currently no effective treatment."
Also something called a Material threat medical countermeasure priority review, Medical countermeasures or MCMs, seems to fit CBR like a glove when it`s ready.
https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/frequently-asked-questions-breakthrough-therapies
Taken from pubmed
Abstract
The maximum tolerated dose (MTD) has been the classically recommended phase II dose for cytotoxic chemotherapy anticancer agents. However, the development of molecular targeted therapies with highly specific mechanisms of action has raised questions about the paradigm of dosing at the MTD. Inhibition of the molecular target may occur at dose levels substantially below those producing dose limiting toxicities. The impact of targeted therapies on our dose selection strategies has been immense; however, defining the MTD in phase I oncology trials still provides valuable information for future drug development. But, the MTD should not be selected blindly as the recommended phase II dose for efficacy testing. Optimal dose selection for targeted cancer agents needs to be evaluated using all available information collected during the early stages of drug development. Definition of the optimal dose may need to be deferred until randomized phase II trials can be conducted. Future clinical trail designs in oncology drug development need to reflect this paradigm shift.