banter and General Discussion, page-6600

Hello again, I want to expand on my previous answer; as I think I know what is going through your head. You have $ at risk and might be feeling nervous, understandably.

Was the writing on the wall the first time around? Or were we blindsided?

Is the writing on the wall now? Will we be blindsided?

So let's start with the inspection. The decision not to do an inspection the first time around wasn't a decision at all; there was simply no possibility here, travel to Singapore wasn't allowed.

The decision to do one now is a good sign, as the FDA policies state that an inspection shouldn't be scheduled if there are material deficiencies:



https://www.fda.gov/media/108969/download

At least they felt this way at the time of scheduling; it will be nice to hear that they actually went through with the inspection.

Next, is it a good sign we didn't (as far as we know) get a 74 day letter? After all, we didn't hear about one last time, right?

Well, the first time around, it is possible that at day 74 FDA wasn't ready to articulate all their concerns about CMC issues, and saved the concerns for their ADCOM notes. But once we had the ADCOM notes, I would now say the writing was indeed on the wall. I and many others refused to see it, and counted on that 9-1 vote, believing FDA would actually follow that guidance.

Now, with the resubmission, FDA has had three years to consider the issues at play, and has been interacting with the company as we prepared our resubmission. We had the guidance of a former FDA official, and delivered a boatload of data way back in October. I would think by day 74 this time, they would know whether they were still going to have a problem approving the assays / CMC issues. So I see the apparent lack of a 74 day letter this time as a positive thing, whereas on the first submission it might have been too early for them to judge...

So I am feeling fairly confident, and have placed my bets accordingly. But still with a bit of a hedge, and never more than I can afford to lose.

Not financial advice


Good luck to you and all longs!