The Novalere ANDA is a much bigger beast and it will adversely affect shareholder value if rejected. It will enable them to finally use their worldwide OTC rights for FlutiCare, rights they actually OWN. It's a hugely important asset for INNV. Furthermore, they can use the original and popular composition of the old FlutiCare as compared to the Perrigo composition of the Westward ANDA.
Shareholders expect guidance, so the CEO has to take chances and make some kind of projection. As said previously, the best indicator he had was how long it took competitors to receive FDA approval. By this measure he gave reasonable guidance.
What else should he have said? That FlutiCare is going to be approved sometime in the next 5 years?
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