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That's up from .02. What drove your valuation up?
That could also be a good thing. If the competition finds the HAL benchmark too difficult to achieve it could draw more interest to buy Elite.
Public Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products (as announced in the notice of availability for the draft guidance General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products), October 31 and November 1 , 2016, College Park Marriott Hotel and Conference Center, 3501 University Blvd. East Hyattsville, MD 20783. Meeting information
Maybe the FDA is waiting until after the 10/31 meetings before they approve anymore ADF's?
Is this Governor on the list of people were writing letters to?
https://www.governor.pa.gov/how-abuse-deterrent-opioids-give-doctors-and-patients-more-options/
I completely agree. This adds forecasted cash flows which in turn increases the value derived through a DCF analysis.
Impressive bid sitting there.
Trading under FAS.V? http://finance.yahoo.com/q?s=FAS.V
Or any investors conference call for that matter.
Here's what I was able to dig up, not sure if it's current: https://www.wsgr.com/cgu/pdfs/tab3-8-kmemo.pdf
BREAKING: FanDuel in talks to acquire DraftKings - Reuters, citing source
She's writing for Hotstocked right now. She can stop talking about news even when she's trying to pull off a credible slam article.
That chart is a thing of beauty. How many stocks offer a double-up every year?
Any word when we'll start trading on the OTCQB? I have about 100k shares and am looking to get to 1m. Just not enough volume right now. Hopefully with the OTCQB we'll drive up the volume.
Name an IR ADF competitor on the market now. Links as well.
That's what I was thinking. Those PR's are fairly predictable if you look back over time.
How is what I wrote spinning or exaggerating? Ask any doctor if they feel insulted that Gerhard thinks they can't differentiate between abuse deterrent and addiction deterrent.
Any Dr. on this board feel free to chime in but it seemed to me that this was a case of professional prejudice.
Exactly, it was comments like that which will render the ADCOM's for ADF's irrelevant. It was them who bought into Purdue's BS in the 90's and now they want to assume current doctors can't differentiate abuse deterrent from addiction deterrent?
Come on FDA, get these clowns out of town and use your own judgement.
That's incorrect. The goal is to make these drugs abuse deterrent and waiting for abuse proof formulations is only going to compound the opioid problem. ADF's are a classic example of progressive elaboration.
For some people $100 is a big deal. Personally, I would t get out of bed for that. I don't really pay attention until I hit 5 digits.
If they're looking for a cure to stupidity that might rival the revenue flows of a cancer drug.
Lots of amateurs are getting their a$$es handed to them today. Weak hands consistently get taken out. Now watch them walk it back up.
From my point of view this ADCOM made me question why we're putting ADF's through this. They were very unimpressive and can't think big picture.
We'll find out tomorrow once KMPH decision is made.
On now, voting kicking off
Get your shares before the ADCOM gives ALO-02 the green light. Big EOD push like yesterday.
It's the middle of the night where he is.
From: Dianne Will <Dianne@elitepharma.com>
Date: April 21, 2016 7:27:43 AM
To:
Subject: RE: PDUFA Date Question
Dear xxx,It seems that most ADF products do have Advisory Committee meetings but at this time we have not been notified of one for SequestOx.
Best regards,Dianne
Can I count on you to give us the Pfizer vote play by play?
There's much more to this but I'll need some time to draft it up. Here's a hint, it deals with the Chinese stance on biosimilars and the correlation between Roxicodone with ELI-200, ALO-02 and Elite's version of ALO-02. You should be able to see where I'm going with a decent Google search. Again, I'll need to draft something up.
Are you kidding me? ELI-200 is IR while the other is ER. WTF?
Monitoring Period Exclusivity. After a new drug is approved for entering the market in China, the State Food and Drug Administration (“SFDA”) will impose a “monitoring period” to observe the safety and efficacy of the drug. During the monitoring period, the SFDA will not grant approval to any other enterprises to manufacture, distribute, or import this drug, unless the competing product has been approved for entering clinical trials in China prior to the beginning of the monitoring period. The monitoring period exclusivity is available for new drugs manufactured in China.
The monitoring period lasts from three to five years, starting on the issuance date of the drug manufacturing certificate.
Because the CAGR is in the APAC:
http://www.prnewswire.com/news-releases/global-opioids-market-is-anticipate-to-garner-us4216-bn-revenue-by-2021-persistence-market-research-567328041.html
North America and Europe have been estimated to collectively account for over 85% revenue share of the total opioids market in 2015. Asia-Pacific is projected to be the fastest-growing market, owing to increasing awareness for cancer pain management, a presence of large patient pool suffering from terminal conditions and reformed regulatory guidelines for the prescription of opioids.
Plus, IR products aren't subject to REMS which is a substantial part of the ADCOM's responsibility to review and outline.
My question to you, if ADCOM's are booked that well in advance then why hand out 6 month reviews? If this were such a high priority then the FDA should not allow ADCOM resources to impede the approval of these drugs.
We shouldn't rule out the possibility that NH is posturing to increase a buyout offer. Whether or not uplisting to the NASDAQ makes sense does not affect it's impact to future negotiations. The threat of organic growth, including uplisting, will benefit ELTP shareholders despite how realistic that scenario is. It's obvious that Epic does not have the horsepower to extract as much profits as needed within the 3-5 year window. If you were to partner with Epic you'd think a product with a smaller revenue base would be the preferred kickoff. Then incur incremental profits off that to wiggle into a partnership with a large pharma. By introducing ELI-200 as the first offering seems a bit off to me with regards to maximizing profits. Something interesting is going on behind the scenes.
Any acquirer will want as much of the 3-5 year exclusivity as possible. Waiting would just decrease the acquisition price. It's a delicate dance in which the clock starts ticking July 14th. That's also another reason why they are trying to push 2-3 more NDA's this year and why uplisting to the NASDAQ is another near term goal. Timing is everything, getting approval, 2-3 NDA's and uplisting are all buyout signals IMO.
I have June 9th I'll take it if either of us are right. That was awesome volume ;)
When you make as much as I do for every penny it matters.