Jack,I've agreed with quite a few of your posts in the past but...

Jack,
I've agreed with quite a few of your posts in the past but you are just plain wrong here. Don't know why you have changed your tone so dramatically - from a 30c by xmas enthusiasm to a 3c in the short term negativism.

I don't have an issue with your general research - it may well have taken many companies up to 12 months to receive clearance. But it is wrong to assume that Oraline will fit in somewhere with the industry average benchmark - in terms of time taken - unless you have some insights into the actual course of the process with Oraline.

There is no indication in your post that you do. Read between the lines a bit - make some further enquiries - and I think you'll find that the process is being expedited quite nicely - and that a clearance before the end of the current quarter (as announced) is a near certainty.

So, Jack, I think you're out by 3 months. I think it'll be Feb-Mar, not May-June.