You fools do realize that NVIV will actually have to complete a full set of trials for the hydrogel right? Haha can't believe on your projected timeline you have PDUFA in the middle of next year. They can submit an IND, not an NDA. Bright bunch of bulbs here.
Ah, the barrage of thumbs down for pointing out obvious facts, still doesn't change the truth. How could you possibly think the hydrogel was going to be approved by the middle of next year? They have to actually run TRIALS first. You know, kind of like how ACRX and TTNP both had to run trials for similar products. It's just heads in the sand for miles on this board, isn't it?
Miker, regardless of your variety of sources (let me guess, this message board and Frank?), you should have the common sense to understand that they don't have any data from any trials yet. Haha did you think they were going to submit an NDA based on a publication in mice and primate models from last decade? Oh boy, this board is a hoot.
You're guessing wrong. Yes there were statements made by the Company and some analysts calling out an "NDA" as the vehicle for submission of Hydrogel, so I employed that extremely conservative set of assumptions (with their arduous period for review) in developing a forward-looking timeline. Frankly, it was the worst case assumption I could make. The 510 (k) submission is a much quicker turn-around and should be a slam-dunk for Hydrogel.
I've seen NDAs accepted based on other than full Clinical data, and I've seen some companies that were pretty creative in answering the FDA's concerns (and by "creative" I mean just that, not dishonest or underhanded) and no few of them were small-caps with very aggressive development plans and not a lot of resources. So I didn't initially think an NDA was out of the question.
Actually it was a question posed to me here that made me re-think that and start looking a little deeper into the process. I've done quite a bit of investment in drug companies and this one, being a device/platform company works in a somewhat different environment so I find myself learning new things all the time.
Again, this is all forward-looking at this point. And it's a reasonably informed "whack" at a schedule without the pretense of a bunch of speculative nonsense about acquisitions and partnerships and the Cavlry charging up the pass to make evreything right. I made the assumption that the scheduled actions would be undertaken successfully since without that degree of success, there's really no point in discussing a schedule is there?
The timeline I posted had an NDA indicated based on information from a variety of sources however it appears that Hydrogel will instead be a 510(k) submission. I was going to update the time line accordingly, but now I don't have to. Thanks for that.
Oh, what the heck - 'll do it anyway. Stay tuned.