FDA approval is still a ways away imo. They must prove first they have the funding and actually restart trialing, then apply or submit their results to the FDA. It is a process imo and will take time imo. What will help too is while trialing is on the way to have regular news, or the initial pop may sink.
I don't think people are "expecting" FDA. It's a possibility. And at .0005, people think it's worth the gamble. All penny stocks are a gamble. But given all of the bad things being said about TCEL from disreputable sources (see a certain video posted again and again) one would expect it to be much lower if the stock didn't have a good chance to go up in value, for the company to achieve some success re: testing