Mm-hmm.

And then that was very new concept.Because there have been co-publication that the, the change in the heart rate variation and the trend of the, the change may indicate the, the risk of having a heart failure.

So the, the, the, the, that so-called feature was developed to say, "Well, the heart rate variation could help physician understand the risk of heart failure." So FDA received the package and, and then at the very end, towards the very end of the review cycle, FDA reached, uh, contact us, "So we cannot approve your application because you have this feature called heart rate variation.

You have no clinical data, and also that you are not-- because of no clinical data, you are not telling physician, the patient what exactly your, this feature does, or how, h-how, what kind of confidence the physician should have.

And therefore you sh- you need to remove this function, the feature from the device." And that would be a huge setback for the company because they have to redevelop this software, firmware-

What do you mean when you say regulatory is an art?

Correct.

Yeah.