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Apricus Biosciences, Inc. Message Board

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  • eugenemc88 eugenemc88 Sep 23, 2012 9:39 AM Flag

    Cox fired or resigned?? Bull

    more smoke

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    • I still say either Damage did not tell us about a Canadian regulatory issue with Vitaros or Abbott is sitting on the drug to negotiate something.

      I checked the health canada site and whatever was posted about pricing is smoke and mirrors. It does not take a year to receive pricing from the drug benefit list. You can find out everything on the approval proces by going to the health canada site (can't post a link). This is what I was able to find on Vitaros:

      A-2010-00918 Information regarding the product Vitaros (Alprostadil) 220 micrograms/100 mg, DIN 02359413 by Nexmed USA Inc. All exempted

      Now I found this on the DIN number

      When is a DIN issued?
      Once a drug has been authorized, Health Canada issues a DIN which permits the manufacturer to market the drug in Canada. For drugs where there is minimal market history in Canada, there is a more stringent review and the drug is required to have a Notice of Compliance (NOC) and a DIN in order to be marketed in Canada.

      The holdup is either:
      1) Abbott looking to negotiate
      2) Health Canada requested batches for testing and something was held up or took much longer than expected or:
      3) They did not receive a notice of compliance or that was held up

      I do not see Abbott selling this drug until EU catalysts unfold where the drug is actually ready to go onsale.

      Sentiment: Hold

      • 2 Replies to zmanindc
      • Some speculation on Ihub on why Abbott has not started sales along with institutional selling does not make sense to me.

        First, the deal Abbott signed did not come with a nice upfront fee so they can take their time. But, money is money and large pharmas do not take a year or more to launch a drug. I spoke to Eisai (multi billion dollar company) about Belviq (licensed from Arena) and as soon as the drug clears DEA review (up to six months) the drug will be available in the US. They said early December or February as the latter timeline. But they directed me to a site my physician could review.Taking a year or more to launch an approved drug is an rare exception and not the norm. So, something is not adding up. I now see why Damage is not getting upfront fees, these country by country deals are an exception and not the norm and I can't understand why he would do this. This might be why Abbott is sitting on the drug and why we have not seen further deals outside Vitaros.

        Some large and well know institutions sold and it appeared we lost another 30k in ownership on the last update. Tutes are not so short-term and they sold, and others are not buying for the follwoing reasons:

        1) Potential for further dilution- The company still has an active ATM and based on my read from 2q 10q $600k was drawn from the ATM and another $550k from warrants.
        2) Dysfunctional business strategy- I can't figure out why this company would by drugs that are not selling versus using a faster FDA 505b to develop their own. You can't really figure out the strategy, it changed year over year.
        3) Direct sales force- Buying that company I am sure scared a few. It is marginally profitable and this company cannot afford to fund a business in the red. They also have a poor track record running business units.
        4) The company will say one thing and then nothing happens, missed deadlines and even some are in my opinion, misleading i.e., signing a partner for Canada by 12/31 and the OTC announcements from last summer.
        5) Abbott taking too long to launch
        6) Warner still sitting on Vitaros
        7) No partners for Femprox,Prevonco and the company put these drugs front and center for over a year (same for Mycova)
        8) No development contracts for the nexact platform - over 2 years

        This is why I have not bothered to buy more and move my average down. As I have stated many times, the only way for retail shareholders, the real owners of this company to prosper with this investment is to sell the company to the largest bidder. If that means firing the BOD, management to get it done I will vote yes to that!

        Sentiment: Hold

      • All they have to do is tell us what is going on. End of story.

 
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