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fondaparinux eu filing, page-8

  1. 1,237 Posts.
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    Wow, ACL/DRR on time with EU submission and still we have negativity amoungst the ranks. The ACL chart looks pretty good of late to me.

    Spacejunk is spot on with time frames but it all depends on the way the submission is handled. Hopefully it is submitted using the centralized procedure which means it goes to the EMA (european medical authority), based in London who ask questions and do the approval process - this should take about 12 - 18 months.

    Another way to submit is via Nuetral Recognition Procedure which means that the submission goes to all of the EU countries for perusal - and each country comes up with their own questions. Obviously this will take a lot longer due to the fact that every country work on their own timeframes and agendas.

    I guess this news isn't classed as price sensative as we are still 12 - 18 months from possible EU approval. Don't expect to hear any approval updates until this time.

    My thoughts on phase II and Phase III trial news are that we will not hear anymore news at this stage. IMO any updates on these trials will be strategically announced just before the split (possible CR) occurs. This would make sense to wet the appetite of possible future investors.

    Yes it is disappointing not to have more regular updates as promised by PS, but I think it is all part of their strategic plan. Let's hope as mentioned that we see the Dollars back in Australia in May and 90% gets filtered back to SHs. Even if we only get a .01c dividend in May, it will show investors what it too come in the future when ACL is brining in $M30 - $M40 P/y (90% of $M30 is almost a .10c dividend) -

    Time will tell.....GL ALL
 
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