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What i posted on SS over the weekend in response to some of...

  1. 56 Posts.
    What i posted on SS over the weekend in response to some of PeeWee/Kellie's "concerns":

    "Hey all,

    Ropren has already been through animal, Phase 1 and Phase 2 trials to determine safety and optimum dosage. What you say about its safety and lack of side-effects is completely true Spicer.

    Phase 3 trials are mainly to show efficacy in comparison with the current "Gold Standard" treatment because Phase 2 trials usually dont show enough significant difference. The fact is Ropren was shown to be so effective that it has been fast tracked for Approval in Russia, without the need for Phase 3 trials. The organisers of the recent Gastro Conference(ie leaders in the field) have stated they will make up a working party to monitor and record the health data that comes out of Roprens release onto the market and its effect. This is an excellent developement and shouldnt be discounted.

    And consider this, if Russia is so easy to get Approval for drugs, and backward etc why is Ropren the first originating from there to be Approved since the breakup of the State? Is SLA the only bio/drug developer in the whole of Russia?!

    Yes, of course, SLA will need to do Phase 3 trials to enter western markets. No one is ignoring this. But considering SLA is a small Biotech, with limited funds, scientifically originating and based in Russia, it makes perfect sense to do trials and release to market there first. The fact that management have been able to do this is outstanding. Sounds like they will be supply constrained in Russia alone until Phase 3 is completed(2-3years?)

    Taking Ropren to the world is the next stated step in their buisness plan. Approval in Russia had to happen first. And yes, this is going to take alot of money and time. Thats where income from Ropren sold in Russia, and/or major liscencing deal comes in.

    From my point of view, management have excelled and I have great faith that each step shall be taken at the right time for SLA and its shareholders

    Cheers

    BB

    (Wysiwyg-"Kellie" is a constant and regular downramper on HC, usually refers to Solagran as Solascam if thats any indication, but I have been nice, for you!! )

    http://en.wikipedia.org/wiki/Clinical_trial "

    Hold tight, all good things come to those who wait :)

    Cheers all

    BB
 
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