Even if the FDA has accepted their update, it is not an SPA. Therefore the FDA always can reassess later. Acceptance is not pushing back. You don’t get a formal letter of acceptance. Therefore updating the clinical trials site, in my opinion, creates unnecessary potential liability if the FDA changes its mind later.
In my opinion, this is about the obtuse and non-transparent regulatory process for “approval” of IND’s and SAP’s. Why would they bother to take that risk given what happens every time they do or they don’t do something, regardless of the case. It’s non-stop criticism and suggestions of bad faith, incompetence, etc. It’s not worth it. Better to not update that site until it is moot. Their job is not to boost the stock price but to protect the company and our investment and get maximal shareholder value in the end, not on a temporary and reckless basis. Their job is not to make life easier for traders on a daily basis.
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