There was more than one reason at the time to move the Mfg to the US. From my email to KB and BOD dated Mar 17, 2020 before there were travel restrictions except to China:
- With the recent advent that 95% of US antibiotics are being manufactured in China there is likely going to be a move to require some amount of critical drugs to be manufactured in the US going forward. Will this effect our CMC plan and if so what is being done to address this?
Based on the answer I believe I was not clear. I was not talking about China being part of Cormedix supply chain. My concern is that the Corona virus issue has brought to light that 95% of US antibiotics are manufactured in China. Due to the CV issue in China there may be supply chain issues for antibiotics in the US. China has even recently threatened to withhold US antibiotics. As a result, I think there is a very good chance Congress will pass a law that will require some or all of these life critical drugs to manufactured in the US. Neutrolin could easily be caught up in this requirement. If this happens the current CMC plan, which is acceptable to the FDA, could become unacceptable. Congress is slow to act but it would be disastrous if this were to happen before Neutrolin approval as it could hold up approval. I am hoping the company, Mr. Armstrong in particular, is aware of this possibility and will have a plan B if this law comes to fruition.