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  • MannKind And Afrezza's NDA Evaluation: What Is The Real Justification For The Advisory Committee? [View article]
    Greg,
    What a great way to debut your writing on SA! I was just starting to look into MNKD and your article was a great starting point to get a rational view of things in order to decide how to trade or invest the upcoming catalysts.
    Mar 27 11:11 PM | 7 Likes Like |Link to Comment
  • The Long-Term Risks About Ocera Therapeutics [View article]
    I am aware of that article. However, I would not agree that it is the next ICPT right now. ICPT's OCA has been reporting good efficacy and safety profiles so far. Until the next OCRX clinical update, I would not make that conclusion.
    Mar 17 06:19 PM | 1 Like Like |Link to Comment
  • Analysis Of The Near-Term Value Drivers Of Spectrum Pharmaceuticals [View article]
    My above analysis, published before the earnings call, and the Q&A between Reni Benjamin, Jason Kantor, and Joseph Keller suggest the importance of maximizing potential with the "consistent" Fusilev market. The combined perspectives should provide valuable guidance for SPPI investors now and moving forward.


    Here are some notable quotes pulled from the 3/6/14 earnings report Q&A:


    Reni J. Benjamin - H.C. Wainwright & Co, LLC, Research Division
    Just very quickly, I guess, just some added color on FUSILEV numbers…?


    Joseph Kenneth Keller - Chief Operating Officer and Executive Vice President
    Sure. So today, underlying demand has been very, very consistent for long period of time now between $20 million and $25 million… But what you see in this quarter, is really consistent with underlying demand. So we feel really good about that. In terms of where the business is, the majority of our business, the overwhelming majority of our business today, is in the clinics. And so the business that was at risk, the price-sensitive kind of place where the generics really focused on the hospitals, that business, for the most part, has gone away. That was last year. Today, the bulk of our business rests in the clinics...


    Jason Kantor - Crédit Suisse AG, Research Division
    …So in terms of FUSILEV, you speak about $20 million to $25 million in demand, and you came in at the low end of that. I guess, I'm just wondering, is demand decreasing over time or increasing over time? And where are you in terms of your inventory levels…?


    Joseph Kenneth Keller - Chief Operating Officer and Executive Vice President
    ...So Jason, the underlying demand is right between $20 million to $25 million, and that's been very, very consistent. So we look at IMS on a regular basis, and we see it now consistent for many, many months...


    Jason Kantor - Crédit Suisse AG, Research Division
    If you want to kind of deconstruct a little bit, sort of let's say what happened in 2013, it'd be pretty helpful...


    Joseph Kenneth Keller - Chief Operating Officer and Executive Vice President
    So I think the -- there a bunch of factors played in, but the key one is the net realized price, when we gave the $80 million to $90 million, it ended up a little bit lower than we thought it would be, and that was the primary driver. The inventory came down a little bit more than we thought, but really, the primary driver was net realized price. And when you look at price now, our net realized price, as you'll notice, has come up quite a bit from the first part of the year, right? It was really low when you look at Q2. A little bit lower than we thought it would be, but it's come up, and now we're at where we should -- it should be consistent as we look forward. So that was the kind of thing that took us a little bit less than we thought it would be.
    Mar 7 01:29 PM | 2 Likes Like |Link to Comment
  • Analysis Of Sucampo Pharmaceuticals And Its Future Potential [View article]
    I will be waiting for the management team to add more color to this quarter and upcoming guidance at tomorrow's earnings conference call.
    Feb 25 06:28 PM | Likes Like |Link to Comment
  • Analysis Of Intercept Pharmaceuticals And OCA's Future Potential [View article]
    Boosts LDL:
    http://seekingalpha.co...

    http://on.wsj.com/1aUIccw

    I have not read anything else pertaining to side effects.
    Jan 12 07:12 PM | Likes Like |Link to Comment
  • Analysis Of Intercept Pharmaceuticals And OCA's Future Potential [View article]
    I agree, it was very good news. However, further clinical results and execution need to be impeccable in order to justify the current market cap.
    It is a pity there are no options available for this stock to carry out a hedged bet at this point for investors looking to get in.
    Jan 9 04:19 PM | 1 Like Like |Link to Comment
  • An Analysis Into Avanir Pharmaceuticals Neutralizes Concern And Reveals Potential [View article]
    'Net loss for the quarter ended September 30, 2013 was $15.4 million, or $0.10 per share, excluding a one-time payment of $20.0 million related to AVP-825'
    They missed analysts' expectation for earnings so I guess I was off by 30% in estimating the earnings.
    But one positive trend is that they achieved 12% unit growth of NUEDEXTA representing the tenth consecutive quarter of double-digit growth
    Dec 10 06:12 PM | Likes Like |Link to Comment
  • An Analysis Into Avanir Pharmaceuticals Neutralizes Concern And Reveals Potential [View article]
    Read this. It is a great summary:
    http://bit.ly/19yQhmH
    Dec 10 07:55 AM | Likes Like |Link to Comment
  • An Analysis Into Avanir Pharmaceuticals Neutralizes Concern And Reveals Potential [View article]
    No one disputes that PBA and agitation are different indications.
    Dec 10 07:53 AM | Likes Like |Link to Comment
  • An Analysis Into Avanir Pharmaceuticals Neutralizes Concern And Reveals Potential [View article]
    “Truthful” is a standard I follow. Going out on a limb, but it might be part of the FDA’s standard too.

    Again, I put zero value on anonymous quotes ...pulled from an internet forum.
    Dec 10 07:51 AM | Likes Like |Link to Comment
  • An Analysis Into Avanir Pharmaceuticals Neutralizes Concern And Reveals Potential [View article]
    No one is trying to enlarge the definition of PBA. You state in your previous comment that PBA patients with agitation were treated beneficially with Nuedexta. “their agitation also reportedly decreased”

    Should Avanir, the medical community, and patients with agitation ignore this outcome?
    Dec 10 07:45 AM | Likes Like |Link to Comment
  • An Analysis Into Avanir Pharmaceuticals Neutralizes Concern And Reveals Potential [View article]
    Regarding your first point, read this:
    http://1.usa.gov/1cyi1Mv

    Regarding your second point, I agree with you that in a scientific lab with unlimited resources, the next logical step would be to test for agitation in MS and ALS patients without PBA. However, humans with Alzheimer’s do not live in a scientific lab at a clinical researcher’s disposal. It is within the medical community's and Avanir’s best interest to evaluate if the Nuedexta drug combo can help this large, unmet need.
    Dec 10 07:41 AM | Likes Like |Link to Comment
  • An Analysis Into Avanir Pharmaceuticals Neutralizes Concern And Reveals Potential [View article]
    There is no existing evidence of off-label marketing. As far as I know, the FDA has not issued any warnings to Avanir and is not prosecuting the company. The off-label hype is derived from a list of anonymous quotes produced by a questionable research firm.

    Nuedexta has been demonstrated to be safe. A physician has a duty to treat and the legal right to request any drug deemed reasonable and thought to help. Nuedexta is a reasonable request b/c it has demonstrated efficacy for treating agitation in patients with PBA. Additionally, a clinical trial is underway to test AVP-923 to treat agitation. The FDA and medical community are aware of this.

    J&J’s settlement pertained to three separate drugs stemming back to the 1990s and early 2000s, in which the company provided kickbacks to doctors and pharmacies to promote the drugs. It was blatant with a significant paper trail. The Caronia case is important. It adds clarity to off-label marketing boundaries and FDA regulation. You should look into it more closely.

    In trying to refrain from adding any more legitimacy to the Gravity Research claims (which might be entirely made up), my article demonstrates that "if" there is any question of off-label marketing, the Caronia case has made the burden of proof higher. Anonymous quotes will not suffice.
    Dec 10 07:33 AM | 1 Like Like |Link to Comment
  • An Analysis Into Avanir Pharmaceuticals Neutralizes Concern And Reveals Potential [View article]
    Thank you! I just sent a note to the editor to change the date.
    Dec 9 12:45 PM | Likes Like |Link to Comment
  • Antares Will Change RA Treatment With The Introduction Of Otrexup [View article]
    Yes Andy. that is a great point! Thanks.
    Oct 14 10:05 PM | Likes Like |Link to Comment
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