fda approval, page-5

Correct Kodak – and so it comes down to how you interpret the sentence:

“We will get FDA approval for AirSonea as we already have approval via prescription,”

ISN already have approval for Wheezeometer via prescription.

So yes there should be no issue getting approval for Sonosentry (the updated device) and AirSonea (updated device with app) via prescription.

The $60m question is whether approval will be granted for over the counter (OTC).

My guess is that they have failed to gain OTC approval for SonoSentry and probably they have abandoned (or at least put on hold) plans for OTC approval for AirSonea.

If this is the case when the FDA approval is granted (and this scenario becomes official) you should expect the sp to fall given projected revenue earnings will be a fraction of what was previously estimated.