The only real difference is that we have 4 to their 1.
Outside of that, it is the same. Implanon is often put back into the same location.
I apologize this is coming so late...
I think it will be approved, but there is really no way to know for sure. Despite another positive trial, it seems that the FDA has the same "questions" as the last time. It should be approved, but it may turn out that the FDA isn't going to let that happen. You can argue it's their job to be cautious or the devil's advocate, but we did get the CRL last time when we thought the same thing.
I could dive into further analysis, but what's the point? Either way, I still think it makes sense to sell right before or immediately after a decision is made (assuming the decision is approval). It will take time to build the market and prove the product. That typically means a decrease in the share price while that plays out.
I had a pretty long history of saying that I thought approval was likely but that the time to sell an FDA approval company is right before the decision - as stocks often sell off on the news and the decision time isn't known. There is no reason to risk not being around when the decision comes through.
I don't need to defend myself, though. Titan got the shaft from the FDA. It should have been approved. I can believe something and still be prudent. Selling some of my shares that I bought at 70 cents was the right thing to do.
Or you can leave it up to the actual doctor to determine what they are willing and able to do?
I'm not sure why the assumption is made that they would be doing the procedure? Same way a gastro isn't going to be treating someone with heart disease.
I wonder if she has any conflicts?
I would love to tear your argument apart... The first few weeks on Probuphine causes the medication to be more than it's steady state, so there is little to no chance there will be a problem with relapse.
That's only one issue with her statement.
You mean the issue created by the fact that less medication is just as effective with Probuphine?
I believe they have as the plasma levels of 4 implants are comparable to 8mg of Suboxone. They knew that going in, so they didn't test on that this time around.
It should gain approval.
One of the major issues last time was the insertion/removal process, which the FDA has lightened up on.
From there, the only reason it doesn't gain approval is because the FDA doesn't want to approve it. Nothing in the data (a lot of data) would support a denial of the drug. The argument that the exact same medication should somehow work better is absurd. The point of Probuphine is to stop that medication from changing hands illegally-- nothing more.
I doubt they even mention it.
Though they will tell us about the need for rescue meds with Probuphine... Of course, the other arm needed them, too. Some just got them in another form.
Unfortunately, it will be halted.
Last time, we were on the OTC and they don't care/have rules regarding halts for material events. Nasdaq will halt it as they aren't a fan of the volatility that is created.
It's too bad because all you'd need to do is buy when the FDA is running through their "negatives" and then sell once Titan starts running through their rebuttal.