Korenko won't go through the De Novo process again. Any company doing buyout will want clinical studies on humans, with data. More for liability than anything.
I would like to see a partnership with big Pharma not a buyout. That would increase the profit. I would like that to be before the de nova submission because I believe FDA reviewers are up for sale (I say this after ELTP's latest delay for BS reason they said in writing they would not require). They could say no to the de nova just to delay and increase the cost of bringing the technology to market if a big pharma company decides its competition they don't want. If someone partner's with us then its more likely no one is working against us. Too many FDA big wigs accept high paying jobs with big pharma, and more than a few get caught taking bribes.
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