which is very toxic to you. So we see the opposite of dose dumping happening with our product. We've tapered it in such a way that it will release less of the payload in a normal situation, so it actually penalizes patients who try to mix our drug with alcohol. Another way drug addicts are abusing oxycodone is by microwaving it. If you took oxycodone and put it in a microwave for 3 minutes to heat it up, and then let it cool off and proceed to pop it in your mouth, you would get dose dumping. You will have destroyed the abuse deterrent technology in oxycodone. If you do that with our product, however, it doesn't induce dose dumping when you microwave it; it operates completely normal. Furthermore, a way that recreational users abuse oxycodone is by dropping it into a can of Coca Cola, which leads to dose dumping. We don't know what it is about it, but this is one of the ways that drug addicts are abusing it. But again, if you do that with our product, we don't see dose dumping happening.
So, the takeaway here is that we're dealing with a number of different mechanisms of abuse, more so than many different players. We believe that we have the best in class here because we are dealing with abuse deterrents through multiple mechanisms of abuse. We're not aware of anyone that has quite the robustness of abuse deterrent technology in one technology platform and in one product. Sure, Teva is ahead of us, and so is Pain Therapeutics, but it doesn't matter. At the end of the day, even if you get out there 2 years after these guys hit the market, what's a doctor going to prescribe? If the efficacy of the drug works exactly the same as oxycodone, the doctor will likely prescribe the drug that is very difficult to abuse (Rexista) rather than one that is only crush resistant.
Yes, it was a good read. They also clarified how the Rexista competitors have minimal abuse deterrence(crush resistance) and that they feel they have the best in class. Also, that most of their drugs are not just exact copies of patented products and that they have their own patents and IP that covers them.
This is an excerpt from he interview with Shampeze Rampertab that was published on Seeking Alpha this morning. It explains the abuse deterrent advantages Rexista has over the competition:
We're trying to deal with dose dumping. Dose dumping is when you manipulate a product to release its full payload in 1-2 hours, so you get really high levels. With regards to narcotics, you get that euphoric state, but the risk is that you can have increased toxicity and side effects and possibly deaths. We've seen people dying of overdoses with various drugs when they tamper with it. Heath Ledger from Batman died of an overdose of Oxycontin in conjunction with red wine. That's all they found in his hotel room. So, that's what we're trying to deal with here.
What does our Rexista oxycodone do? Well, the main thing that all these products must have is some kind of crush resistance formulation. Rexista has that too, and we have a patent application that recently got published. The reality is all products that are out there can be crushed. If you can go buy a $20 coffee grinder, throw a pill in it, and you are left with some flakes and powder. If you snort our product in the presence of moisture, it's going to get very gummy and pasty and clog up your navel cavities. If you try and pop it in your mouth and inhale it into your lungs like a dry powder inhaler, it will, once again, get clogged up in your throat and you will have to cough it out. If you try to dilute our product in water, it will get very viscous and it's not syringable, so you can't inject it.
If you take that same powder and free base it, which is when you put a powder on a spoon and place a flame underneath it to inhale the vapors, it will spontaneously combust. And if you extract the vapors that come off that burning, there's not much of the oxycodone left, so you will have essentially destroyed our product. If you try to take our once-a-day product with alcohol, that full payload will dump into your body in 1-2 hours
I wasn't able to listen to conference call. I asked people to give a recap this AM and no one was kind enough to do that. It was like 5th grade recess here today- short versus longs and bashers versus pumpers! If they truly have a fix, I don't see why this all cannot be resolved by years end...
I consider myself an investor and not much of a trader. But I have learned a lot from traders and am just being realistic on what is going to happen here. I can wait, others need that money for other investments and I do understand that as well. Having watched many small cap bios the last several months, the drop is never over in one day. Trust me, people will do their best to beat this thing down as far as they can. $5 is my target and I will stick to that. If it doesn't get there, I can live with that as well. I do really think ACRX will get these problems resolved and approval will be in 5-12 months.
I agree engineers can fix this. If its just software or an electrical component change that can sometimes go real quick. But if the circuit board needs to be revised that could take a while. If a tooled mechanical part needs to be changed that could take a while too. I am hoping they already have fixed this problem and they only need to test and then submit data. If they need to troubleshoot and chase this down, they better get some good engineers on this quick... Because changes take time.
I have a small position purchased in $7s. There will be some bounces as you said. But I just can't come up with a scenario where it doesn't continue a downward trend for 4-8 weeks. I am holding off on buying and my target is about $5. May not get there but will wait it out.
I don't think the drop is over. I think it will continue to drop for a few weeks. But it did drop really fast with volume, so I may be wrong. I know someone on here reported short interest increased today. Is that true and how would they know?
I just have a small position in ACRX. I have set my target too add at $5. I don't know if it will get there, but am watching closely. My feeling is the negativity and the conspiracy theorists will push this down a little more over the next 4-8 weeks. I am thinking AF will do what he does best- bash small caps when they are on the downtrend. However I do see this rebounding nicely. Good luck.
Yes, will come soon. I wait patiently. It is kind of interesting to see some people who sold out of the stock- some at losses, some not- continually come back and bash the company. I know when I have sold out at a loss, I have moved on and never looked back. I really don't take these people for what they say they are and understand that there are many ulterior motives on YMB- including pumpers. I would like to think these message boards are for intelligent discussion. But usually that is the exception not the norm. Roberto Pedone's new article could be good for a short term pop in IPCI's price. He is a trader and I have certainly seen his articles move price for a little bit- but most often they do not hold.
Yes, he is wrong often. He also hates to admit he is wrong. Should be interesting to see what he says tomorrow. I am guessing this is the unlikely event when his buddies are on the long side and he will feel obligated to write a positive article so they can out of their position.
Pete- Although I think the stock will be beaten and manipulated down the next 4 to 8 weeks, I also believe you know what you are talking about and what you have posted makes good sense. I have dealt with agencies(not the FDA, but similar) in the past and communication with the agency is key. In my dealings, I always try to stay in contact via phone calls, etc. It seems kind of ridiculous to me that these minor details(if they truly are) could not have been cleared up with a couple phone calls or a brief meeting. But what people are telling me is the FDA doesn't do that? What a great agency to deal with...
I am holding a small position. I really see people heading for the doors tomorrow. I think best case tomorrow is a drop to $7 or $8. I hope I am wrong but I think many longs will sell, hoping for a better buying opportunity in coming weeks. Also I don't think shorts have too large of incentive to cover at this point. I hope I am wrong and the stock can hold up tomorrow but I really have my doubts. Good luck all.
They both look bad here. But ACRX looks worse as this is their baby and they did not do everything in their power to get this thing through. To me they dropped the ball. How bad? Tomorrow morning the market will speak to that and then we know...
That thing with the website leak is going to bring in the ambulance chasing lawyers. I think it will get slaughtered as well. Not all Monday but in coming month or two it will hit yearly lows. Will go back up. I just need to figure out the right time to add. Good luck all.
They found a functional issue with device. Seems not to be safety related but functional. Here is what CRL said:
The requests include provision of bench data demonstrating a reduction in the incidence of optical system errors which require premature drug cartridge change
Seems to me the device wasn't electrically/mechanically/software/functionally tested properly or they should have found and corrected this prior to submittal.
So after they filed the NDA, they resubmitted data for some reason. The FDA did not review this data prior to their decision. I think ACRX management knew they had a zero chance for approval this go round. Yes, if the device works as they say it does, they will get this worked out and likely get it approved. But how about letting shareholders know that they had to submit additional data? This opens them up for all sorts of criticism, short attacks, ambulance chasing lawyers, etc. It's gonna be a bad month or two if you plan to stay long. I only have a smallish position that I had a good entry on. I may considering adding some if it drops low enough. But certainly I personally think Monday will be the start of the drop and it will continue for some time. To what degree, I do not know, but this will be ugly...