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That is simple conjecture. Yesterday's stock crashing is entirely due to the stock vote. Those that see otherwise are being ignorant.
Let's let the FDA speak for themselves. Funny how you have been saying for weeks that it will get the oral abuse label. Why backtracking? Truth finally being realized?
Depends on what labeling FDA allows Eli-200. It could be worth much much more if we get labeling for nasal, IV & oral. If FDA doesn't delay ruling we will hear by July 14th.
Yes, it absolutely matters as it defines the tech itself and not just Eli-200. This is why I think the stock tanked during Pfizer's Adcom vote yesterday. We have a very similar pharmacologic tech to theirs. Theirs is struggling and can be easily extrapolated that Elite's tech will have the same issues. PFE claimed 30 solvents were used during trials. Elite used half this amount. What is to say Elite even tried using the same solvent that is causing extraction concerns? We simply don't know until the extraction data is made public.
On another note both Teva & PFE had their adcom's delayed. I hope we still hear back from FDA timely.
The purpose of this post is to show that not everything is puppy dogs & rainbows as some on this board would like you to believe. We are not out of the woods yet...
"We will follow with a generic once this product is available in the market for us to compare ours then." I think we still have a few months ahead of us.
Not exactly. FDA needs to give final direction.
I actually enjoy his tidbits of TA that I watch now & then.
Today's excitement is another good reason to get off the OTC.
How do you know that? I believe Elite used 15 household products. It does not mean that that specific solvent was included in our trials. In fact, since the products are very similar it raises more questions on whether it would have the same results as Pfizer's extraction issues.
You do realize this is not good news for Elite, right?
I also want to see some good Q over Q increases.
Will be interesting to hear how oxy IR are fding as well as Israd.
I agree 100%.
Setting value pricing is very complex. One must build in both current competitive factors with an eye also on better tech that will enter the market. A larger pharma has the marketing clout to leverage relationships and sell crap vs Elite's potentially better tech. Products don't just sell themselves, especially in the pharmaceuticals world.
Awesome day indeed. I disagree with triple-digit growth on rev. Last quarter didn't sequentially increase over the prior. It did over prior year, but dipped from qtr to qtr. That was a disappointment for momentum of generics. If revs stay flat we are looking at about 40-50% increase over prior year. I don't see anything close to triple digits.
Still a long way from Nasdaq requirements. Next 6-12 months will be exciting with other near-term submissions.
"Oxycodone can be selectively extracted from intact pellets by a number of straightforward techniques and certain common solvents appear to be capable of removing naltrexone selectively from crushed pellets, the review said."
I am not sure I agree with your definition of oral ingestion. If so, the FDA would have multiple definitions, which is entirely possible. I have read many FDA docs about oral ingestion that mean to just swallow pills whole. This is the only way, to my knowledge, that SequestOx can be abused.
It raises more questions on the validity of the drug deterrance.
Just perused a bit. One study showed better results of disliking than crushed oxy & hydro but not as much as placebo. Going to be interesting read.
Briefing docs posted.
You are right. I had to research to refresh my memory. Sales are off to a decent start. Egalet received about $2M in royalties from their first quarter, with mid-single digit royalties translates to about $100M in gross annual sales based only on their first full quarter so I would expect the ramp up to continue to climb at a pretty good clip.
I think Elite could do much better than this due to SequestOx having far greater benefits.
Didn't Oxaydo receive ADT labeling in IR space?
Same author mentions the 18-2 ad comm vote against ADF labeling in separate article. I think it is earlier in May.
I somewhat disagree. I think they have a niche market. For example, opiate abuse is an issue with prisons. This is a great market for them to tap into to insert the subdermal implant, set & forget for 6 months. They would need to continually be weaned off the drug over time, but it could help many live normal lives without having to remember to take a few pills at a specific time.
And on what basis do you think it would flop? There is nothing even potentially close to SequestOx on the market today or near future.
He already does like every other company. They are called 10-Q's & 10-K's with a sprinkling of an investor deck now & then. Amateur investors expect otherwise.
If the study started recruiting late 2014 & follows patients for 36 months, we have at best another year not including analysis.
Not yet. What you are seeking is divulging our competitive advantage and eliminates any element of surprise to competitors.
Completely agree with your comments.
Not always entirely true. I have seen stocks not get a spike with FDA approval and actually sink afterwards. In the end sales are the ultimate proof that the market may demand before getting a meteoric rise. Even as Nasrat has stated, if Elite gets just a few % of the market the stock will go up a few dollars. He is talking achieved sales beyond FDA approval.
That is the billion dollar issue no one can yet solve.
Of course Purdue will sew, but the delay will further push out revenues, slow down additional drug trials and put a big dent in ELTP's pocketbook.
I think without having the pre-FDA Advisory Committee scheduled yet we have an equal chance of Eli – 200 being approved without the advisory committee or a PDUFA date being pushed back due to the new technology.
Yes, sharecount is up significantly. My personal return is about threefold due to the Nasrat's solid business plan & execution. I am expecting my return will be going much much higher over the next couple of years.
"Yes" is checked. What is your point in validating everything was filed with SEC?
Legislation is never forward looking and is always incredibly slow. Will be interesting to see how SequestOx is priced knowing ADF's aren't competing for price, but the deterrence innovation. This will be critical to Elite's near-term success.
You are assuming profit of $40M, which means much higher revenue, which means if you were trying to create a comparative scenario you forgot COGS & Operating costs. Sales does not equal profits.
Unless Scottrade has made changes, for OTC stocks, they charge a trade fee + 0.5%, which depending on the volume of stocks can be a significant amount.
Yes, funny that I just mentioned a PE of 20 earlier today. Several could equal $2.10.