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Under that logic how would you explain the price action on Collegium?
No kidding, obviously not KMPH...
I wonder where all that institutional money from those NASDAQ investors will go?
I think KMPH pushed this through the 6 month review in an attempt to confirm bio-equivalence and get it approved with or without ADT labeling. Why? Because they are bleeding cash and desperate for revenue streams to support their R&D.
Elite on the other hand has a much better capital structure and no need to throw Hail Mary's.
In what way?
It'll be interesting to see what the final ruling is from the FDA.
Wow, I know they approved for the indication but the abuse labeling wasn't. Could you send the link?
It didn't look like it. FDA could always reverse it but it was overwhelmingly shot down for abuse labeling.
Yup, there it is, 5x2.5x7.5, so where is that 2.5?
Never mind the minimum notification of 14 days. Now if you made that statement on June 16th you may have been on to something. LOL
Never mind the minimum notification of 14 days. Now if you made that statement on June 16th you may have been on to something. LOL
Now that's flawed logic if I've ever seen it. LOL LOL
I suppose the entire month of September is scheduled too? LOL
Around June 9th for the panel. As pointed out, the variance between panel date and notification is too big to pinpoint a date.
34 days prior to 6/9 would be 5/6, 50 days would have been 4/20. We could hear any day now or, with a minimum of 14 days notice, we could hear the last week in May.
However, the PDUFA Date minus the FDA Advisory Meeting Date ranges between 30 & 35 days.
7/14/16 minus 35 days = 6/9/16. Then we subtract 14 days from 6/9/16 = 5/26/16.
We should hear about an FDA Advisory meeting by the week of 5/22 at the latest.
Correct! Thanks for confirming the date variance between KMPH & Collegium!
Besides, who'd structure a deal 5x5x5???
A deal structured 2.5x2.5x10 is a much better risk adjusted proposition for Epic.
Incorrect, the first payment was 2.5 million.
"On January 14, 2016, Elite filed an NDA with the FDA for ELI-200, thereby earning a $2.5 million milestone pursuant to the 2015 Epic License Agreement."
"The first milestone payment was due and was received upon signing the agreement. Subsequent milestone payments are due upon the filing of a New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) for the Products and upon receipt of the approval letter for the NDA from the FDA."
Therefore the other 2.5 million was earned when NDA was filed and 2.5 when the agreement was signed.
rollin_;)
OK, I'll help you out:
http://ir.collegiumpharma.com/phoenix.zhtml?c=253995&p=irol-news&nyo=1
Just one example.
So the content provided in the investors presentation is incorrect???
SequestOxTM Sales & Marketing Partner
• Epic Pharma LLC: a license for sales & distribution;
• $15 million in non-refundable milestones;
• $5 million already received;
• Royalty to be paid based on net sales;
• 5 year agreement;
• Elite manufactures on cost plus basis.
http://ir.elitepharma.com/Profiles/Investor/Investor.aspBzID=2258&from=du&ID=66904&myID=16024&L=e&Validate=4
No links I care to share, gonna have to sleuth around.
There's no correlation, trust me. I've gone into this in nauseating detail.
Fair enough, the information I've been reading is completely applicable to this investment in my opinion.
We should have a good idea tomorrow afternoon.
Nothing yet. The FDA requires 14 days notice for an advisory committee meeting. Obviously they wouldn't back it up all the way to 7/14. I think we'll hear by the first week in June.
As an investor, reading those reports was enough for me to hold off.
No they haven't said that. The FDA experts have submitted their report of the findings for review. A look into those documents would suggest their product is no more abuse deterrent than other combinations of hydrocodone/acetaminophen.
Final ruling won't be given until the committee gives their evaluation and is taken into consideration by the FDA.
But who knows, Zohydro wasn't recommended for approval but the FDA approved it anyways.
It's out there.
Read the FDA & KMPH presentation yourself.
I'm not so sure KMPH's application gets approved.
Like it's 1999?
Yes, it's been received.
Indirect news is out there this morning, just need to know where to look.
"Clearly there seems to be regulatory movement in terms of abuse-deterrent formulations playing a role in combating abuse of opioids. After further validation of their ability to live up to expectations, they may become the “new generation” of opioids, and make non-deterrent formulations of opioids obsolete. "
Anyone have a guess to who Kevin Zacharoff, MD is??? (answer is in the link below)
https://www.painedu.org/articles_timely.asp?ArticleNumber=18
" Often fueled by media attention, the issue seems to be worthy of concern. Indeed, even in secondary school students, the numbers can be intimidating; 20% of 7th - 12th graders use prescription drugs non-medically, with a significant amount of those medications being prescription opioids. The sources of abused or diverted opioids are quite varied, and can include:
-Theft from the manufacturer, distributor, or pharmacy
-Theft of prescription forms from clinicians
-Theft or sale from the patient for whom the opioid was prescribed
-The Internet
-Drug dealers
Although opioids are often abused in the manner in which they were intended to be administered (e.g., oral), there is a significant amount of abuse after alteration (tampering) or extraction of the active ingredient has taken place. In light of these facts, along with the diverse routes of availability, pharmaceutical companies manufacturing opioids have invested a large amount of resources towards the development of a number of different approaches to resist or deter abuse and misuse."
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM498312.pdf
My favorite is your guarantee that ELI-200 won't receive FDA approval. A close second is your 300m market cap.
Wouldn't minimal use as prescribed by a doctor interfere with their rights to abuse opioids?
Can't have it both ways. Either you completely legalize it similar to marijuana in Colorado or you put controls in place.
So which is your stance?
So how many of those examples constitute inelastic demand? Not such a broad bush now huh?
It's that whole supply and demand concept that trips some people up.
So those three bowlers rolled strikes because they were great bowlers? Just like those stocks went down because they were dogs?