CMQ 0.00% 8.3¢ chemeq limited

fda - ers - fyi

  1. 4,086 Posts.
    G'day,

    I note that there have been several mentions of the situation re CMQ, it's FDA approval and ERS (Expedited Review Status).

    I knew that I had some information on this but it was an email from the company and I have changed machines and the email was in an archive. Anyway, after a lot of fiddling around, I have managed to extract the email from the archive.

    Looking at it now, I wonder if it was worth the effort. lol. I pass it on here with no comment and hope that it may be of some value. Just be aware that this was more than 18 months ago and all sorts of things may have changed in the interim (the price certainly has!).

    24th October 2001.


    Dear sir/madam,

    Your September 2001 ASX announcement contains the following.

    Research-based pharmaceutical company Chemeq Ltd [ASX: CMQ] today
    announced that the US Food and Drug Administration (FDA) agrees that
    CHEMEQ(RTM) polymeric antimicrobial will be a "therapeutic
    breakthrough" and following further substantive information, will
    propose fast-tracking the company's application for the drug's approval.

    This implies that CMQ will receive a favorable response to it's application
    for ERS (Expedited Review Status). As I can find no mention of CHEMEQ at the
    FDA web site, I would be pleased if you would be able to answer the
    following questions.

    1. Is there documentary evidence to substantiate the ASX announcement.

    2. When would you anticipate ERS being granted.

    3. Assuming the granting of ERS, when would you expect full FDA approval.

    Thanking You in advance
    XXXXXXXXX


    Dear XXX

    Thanks for your interest in Chemeq.

    In response to your questions:

    1. There is documentary evidence to substantiate the ASX announcement - the
    document itself is not for publication though. Chemeq does have that
    document..

    2. ERS is not likely to be granted until early next year.

    3. With ERS, full FDA approval would take 2-3 years. Without ERS, approval
    would take 5-6 years.

    Yours sincerely

    XXXXXXXXXXX

 
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