No label is exactly the same as no approval. They can't sell without AD label. This is a massive massive overreaction. I think the CRL is procedural in nature and relating to timing issues.
I think that the company is factoring in stricter FDA standards in 2016, which might be caused more by undertones of political concerns than anything else.
What is your take on overall management quality? Is this another CMRX?
Well, "jillbloes", I have this to say:
1) Yes, one member did mention it. You have selective memory. Remind me again in two weeks and I'll point out the exact point in the webcast.
2) Take an anger management class. Is there a point to embarassing you when you spout off like that?
3) People can die from taking naltrexone right after oxycodone because of the sudden withdrawal.
There is, according to what I have read. I don't know if it exists in an IR formulation, but definitely an ER formulation. You get sudden withdrawal and could die by taking a bunch of naltrexone right after you take oxycodone.
The prodrug is KP201, but the product is KP201/APAP. It may be that the FDA is more interested in having KP201 as a replacement for just hydrocodone, which does demonstrate much larger differences in liking through the nasal route of abuse. Hydrocodone is much more abusable than Hydrocodone/acetaminophen, except when the hydrocodone is removed from hydrocodone/acetaminophen with just water, so the FDA is really contradictory here.
I think we need clarity as to what the FDA thinks about the current drug as of this moment. Kempharm says they've been in productive discussions with the FDA, but what does that mean? Investors need more information.
Totally. But some might also die. As meifud pointed out, Elite's drug won't have as high a concentration since it's an IR drug. I'm just pointing out some apparent inconsistency with the FDA and adcomm here. They want to save people from dying by approving a drug (Pfizer's drug) that may actually kill more people.
I mis-typed that. Max is 90 days under major amendment.
They actually submitted the amendment on July 6.
They have been in continuous discussions with the FDA on the labeling for the past month. They under-estimated the importance of the ER-focused Category 3 studies in terms of how the advisory committee views abuse-deterrence. I think that the FDA, due to political pressure, cannot just throw away the advisory committee's recommendation regarding labeling, however wrong their thinking must be. So, due to that, they had to provide a different label that maybe modifies some of the language, with the FDA's recommendation to do so... To provide a different label means a submission of a labeling amendment.
I don't think it will take very long. I am still trying to find the appropriate regulations but the max would be 30 days (major amendment), although I think labels are minor amendments.
If they are burning 25m a year, it will last four years. However, I imagine the cash burn will increase once they have a product, as they will need to hire sales staff. Though, I don't agree with that strategy and I think they should just license out the product, and the technology, to one of the big pharmas in the space like Teva, Pfizer, Purdue, etc.
While lollipopp69 is frequently acerbic or just plain wrong, what he was trying to say is that it is very difficult to find out because there are so many cancer cases and a very large amount (in terms of numbers, not percent) of them do not have a definitive diagnosis.
I would like to note that only one person on the advisory committee asked the FDA about labeling language regarding naltrexone exposure of an experienced opioid abuser (the risk of death and so on). The FDA stated that they had a strong warning about it, and she suggested that the FDA look to see if they can make it "stronger".
I also noticed that the company did cite the naltrexone risk as an abuse-deterrent as evidenced by a poll of abusers.
This all tells me that, perhaps, the ad comm (and maybe the FDA) simply does not care if the odd abuser dies trying to snort this thing.
Am I cynical?