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This is absurd nonsense. SequestOx has no bearing on the rest of the pipeline.
I would say emphatically that most of what has been said has been true. Everything about the technological platform has been validated, so everything there has not "been wrong". Everything about all the studies has been correct. What some of you naysayers ignore is the fact that there are other drugs coming. Furthermore, there is no way SequestOx is dead or will be dead.
All lies
You need to improve your reading comprehension. Follow the clues of who said it's getting worse.
One doesn't sprinkle it on just any food, nor is one supposed to sprinkle it on food that requires chewing. It's specifically apple sauce bc apple sauce doesn't require chewing and in fact, every single idiot on this planet is smart enough not to chew apple sauce
Can you cite a specific quote where Nasrat was dishonest? I am not concerned about how "it appears".
I say let's trust Nasrat and the team. They know a hell of a lot more than everyone on ihub combined times a lot.
Didn't you say that once?
Post some proof that they actually had to wait the full 30 days. In the real world, the FDA does what they want to do. If they want to meet in 10 days, they'll meet in 10 days. Do you think any government official follows policy?
Could be days or could be weeks. You are muddying the waters as well. There is nothing in Nasrat's words that says weeks. Even if there is an official policy of 30 days, that doesn't mean they actually wait 30 days.
There is no point in doing a RS until they have the fundamentals keep the sp up. Otherwise, it will just drift back to where it is now.
I guess that should put you back on since it saved a lot of money
You are completely correct and Nasrat added this won't be an issue for the other 5 applications.
He did mention something about facility toward the end when he discussed/highlighted the other 6 items listed. I couldn't understand what the issue is but he said the label/safety issue was the only issue of note.
He also stated it was "done", as in taken care of, when he covered the facility issue.
I think you covered it perfectly. A BE will have to be done, which would have already been done. Everything is pretty much standard and done the same with other drugs.
Nasrat will meet with the FDA to confirm if that will be enough to satisfy them. They could start today if they knew exactly what will satisfy the FDA.
yep. You nailed it
Go here and listen. Well worth it. Jump to 2 minute point if want to skip opening stuff. Listen to Nasrat's passion.
audio replay
I know what the easy fix is bc Nasrat told us. I don't know if that will satisfy the FDA bc I don't know if they are honest or competent. If the easy fix isn't good enough for SequestOx, then all the other drugs that used the same fix should be pulled until they do whatever Elite has to do.
I seriously doubt there will be an adcom. The adcoms are for opioid drugs without deterrent technology.
Yes, it went very well.
1. FDA changed their minds. Blame is squarely on them, but problem is easily resolved but must get clear direction from FDA
2. Has no effect on ER technology
3. Goal is total of 6 applications by end of next year
4. Nasrat spoke like a warrior. Basically said we won't roll over and play dead. We will resolve this and move on. He's not knocked over by a breeze like many.
I'm simply pointing out that Nasrat referred to him as Dr. So and so.
Yes, SO is solid. Nasrat specifically covered that. He basically said the CRL verifies the science and that the goal is 6 total applications by the end of next year.
He repeatedly also stated this CRL doesn't matter for the ER products forthcoming.
Hedging would have been best, but at that time they didn't have an abundance of money and probably didn't want to waste any. Management didn't assume anything. Nasrat specifically cited the doctor at the FDA who told them it was a labeling issue.
Should they have hedged against everything? There's an infinite number of things they could hedge against. This all comes down to the FDA changed their minds. Nasrat made that clear.
Did you even listen? The issue was discussed with the FDA all the way back to 2014. The FDA said is was just a matter of labeling. Therefore, I guess you have no "bigger concern" now. Glad I could make you feel better.
I repeat, ELTP DID NOT MISS ANY SAFETY ISSUE. The FDA changed their minds.
Nasrat said they knew about this "issue." The FDA told Elite it was just a labeling issue, so they didn't include a study regarding this issue. Now the FDA decided it's a "safety" issue. Nasrat will meet with the FDA to decide exactly what is acceptable to the FDA, so they won't change their minds again.
killing time mostly. What is your reason? I mean other than the obvious.
I'll stop believing in conspiracies when money ceases to exist. I have no concern about the CRL or the stock price or a drop or dilution.
According to the bid and ask, it will be between .18 and .20 at open. I imagine the shares will be bought quickly. Hard to know how many shares the manipulators are willing to sell.
Which could easily go back to the regime change as Lasers has discussed. Ultimately, it's all nonsense. The FDA could easily allow this to be resolved on the label. If I take two tylenol and it doesn't help, I don't take two more after an hour. Some morons do; another study won't change that.
What you should be hearing is that this CRL is the direct fault of the FDA. Nasrat clearly said this would have been addressed if the FDA did not previously state that this was a labeling issue. The FDA effectively moved the goalpost.
Yes, but only bc the FDA changed their minds, as bureaucracies usually do. First it was a labeling issue. Then, it became a safety issue.
According to Nasrat, you are completely and utterly wrong. He basically said the technology was validated by the CRL.
That was awesome. We don't roll over and play dead. We solve the problem and move on. Awesome. How can any decent person not love Nasrat?
That's great information. Great minds can disagree on what's best. The FDA may want different wording on the labeling. That doesn't mean the FDA is correct or knows what's best; it just means the FDA has the final say. There's an infinite amt of possibilities involving manufacturing, etc. It's just like any other legal matters; if they want to find something wrong, they can.