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IntelGenx Technologies Corp. Message Board

yogisteve77 3 posts  |  Last Activity: Mar 28, 2016 10:27 AM Member since: May 17, 2012
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  • Reply to

    CRL

    by monasticdude Mar 18, 2016 11:59 AM
    yogisteve77 yogisteve77 Mar 28, 2016 10:27 AM Flag

    If you want a dialogue based on facts, then you should start using them - instead of the conjecture of most of your comments. You do not know the basis of the Kangio CRL - the Bendeka patents can (and will) be supported - claiming the speed of a 505b2 submission based other drugs does tell me a lot about your 'pedigree', each submission is totally independent of another (and given the past issues around this drug don't expect a quick approval).

    Finally you seem to be proclaiming gloom and doom for EGRX based on this one drug, and that's ridiculous. The item Teva is replacing Bendeka with only has about $800M in yearly sales (and then the royalty is 20%). As stated in the previous reply the big prize for EGRX is Ryanodex - which you not surprisingly didn't mention in your post just got NIH backing for an animal clinical for treating Ecstasy and Meth OD's. They should also get approval for EHS shortly. These are very large applications, and is 100% owned by EGRX. Stop your speculative / fact-less comments if you don't want to be challenged on them.

  • Reply to

    CRL

    by monasticdude Mar 18, 2016 11:59 AM
    yogisteve77 yogisteve77 Mar 25, 2016 1:00 PM Flag

    That's pure speculation on your part. Without knowing what the new formula includes chemistry wise for stabilization, there is absolutely no way to know how easily / difficult the approval process will be.
    Even if relatively benign changes though don't in anyway insure the 505b2 filing will be quick and easy. I have spent my working life in the Rx business, your comments are either naive or disingenuous.

  • Reply to

    CRL

    by monasticdude Mar 18, 2016 11:59 AM
    yogisteve77 yogisteve77 Mar 24, 2016 2:01 PM Flag

    you seem to gloss over this situation with a rather simplistic evaluation. let's assume someone does formulate a stable Lyos, it would still require clinicals and new approval which makes it something that is years away at the least. In the meantime Teva will have converted their $800M a year Treanda business over to Bendeka by the end of April at the latest. At a 20% royalty rate to EGRX, that's not bad. You are also assuming a new Lyos would be priced the same (which I doubt very much). Price pressure from insurance is only getting more acute by the day.

    Finally EGRX is not a one trick pony. According to the CEO's recent earnings call, they will hear from the FDA by the end of March regarding the expanded label for Ryanodex for EHS. CEO has stated many times Ryanodex will be their biggest money maker. Other expanded label applications are for Ecstasy and Meth overdoses. This (plus several over pipeline items) are the future of EGRX. In the meantime Bendeka will start pumping in $10M per month immediately (not counting milestone royalties).

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