This appears rather a strange suggestion to "unload" the company in light of the facts related to the opioid pain med market. But before addressing the competitive market issues, allow me to point out that the very reason for an ADCOM is the need for additional data/facts/information, suggesting a less than compelling earlier argument by the firm submitting the NDA (PFE). If there is confusion, it is less about the NDA and more about the evidence and argument being offered by Pfizer. And, it is incorrect to imply the issue is about recommending any new opioid when the FDA has addressed this issue...they are reluctant to recommend any new opioid...sans abuse deterrence. And, absent an ADCOM and given the evidence that a year ago 40 of 41 NDA submitted under priority review received approval before the PDUFA date, one can argue the "if approved" more likely is "when approved". While there is always that outlier, I like the chances it is approved and have placed my bet.
Nonetheless, that still does not address what may be the bigger question about the competitive market. I have said this before but for all the new posters reading, the message bears repeating because it makes clear we are NOT talking about a declining market but a growth market and here is the logic...
...We know from the demographic and global consumer changes occurring that the market for pain meds, in general, and opioids, in particular, will see sustainable growth for the next ten years, at least. And, as has been noted, the socio-political-legal-regulatory aspects of the external environment will only serve to make the market more competitive, not less. That competition will be governed by a move to ADFs (abuse deterrent formulations); which will form a future barrier to market entry. While there remains some debate as to what the percentage of ADFs are currently in the market, it appears to be no higher than 11%. Moreover, the current market leader, Purdue, is struggling with legal issues that directly threaten its 28% share of the market - less with an ADF tipping point.
So, what we can glean from the above? It is that the opioid pain med market remains the Wild West of pharma opportunity. With ADFs set to form a tipping point and no single company in control with a sizable share of ADFs in the market, it remains that there exists an opportunity that does not require a best-in-class product to compete; a point made clear with Mannkind and its diabetes drug Afrezza. However, in the Wild West opioid pain med market, ADFs of all kinds will gain footing (until they prove to be ineffective or priced poorly) and there will be no reason to believe that Elite, with an FDA approved tech that can be used on a range of drugs, will not capture a notable share of the market. In fact, if we consider a key statement in the FDA April 2015 guidance we will see some interesting points in the following (on page 2 of the following link…http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm440713.htm. It states…”The FDA intends on taking a flexible adaptive approach to the evaluation and labeling of potentially abuse deterrent products.” They go on to say…”The FDA intends to consider the totality of the evidence (their emphasis) when reviewing the results of studies evaluating the abuse deterrent properties of a product.” Sounds like there is no one way the FDA is looking to crown a single abuse deterrent product/approach. I guess that is why Acura, Collegium, Pfizer and even Purdue have or are close to having approved abuse deterrent products. They are all very different, with none noted by the FDA as a gold standard, suggesting that others may enter the competition if they are within the seven product areas identified.
Based on the positive data from their P-3 and granted a priority review, it appears Elite will soon be competing in a changing and growing market. Now, whether a big pharma firm wants to buy Elite because they have a proof of concept is another matter. One might say that, in light of the slow growth for pharma, more consolidation (M&A) is likely and I would be fine with Elite's BOD accepting a well priced offer. But "to unload" is such a pejorative term and an action that would be deleterious to we investors. I much prefer a negotiated sale.
You are misunderstanding the entire point of the ALO-02 ADCOM conversations conclusions.
Quite simply the ADCOM members are looking for higher standards guidlines from the FDA in which case both Teva's Vantrela and Pfizer's Troxyca ER would have both been rejected.
Based on current FDA guidelines both Teva's Vantrela and Pfizer's Troxyca ER were voted acceptable but would require label warnings.
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