CMQ 0.00% 8.3¢ chemeq limited

ers and fda approval--q and a

  1. 22,691 Posts.
    BTW, thanks to ForrestGump who pointed me to a letter he wrote to CMQ on 24 Oct. 2001. ______________________________________________

    * * * My questions to CMQ:

    26 July, 2003:

    Dear Dr Melrose,

    I serve on some major chat sites:
    Ozestock, Hotcopper and the NZ Sharetrader.

    I promised them to write to you with the aim of obtaining some answers to the following questions pertaining to:


    ERS--FAST TRACK,

    1. When do you think that ERS can be granted?

    CMQ made a reference to FDA Fast Track on 4 Sept. 2001.

    2. When do you expect Full FDA approval to be granted?

    I did sent these questions to CMQ on 7 July but have not received an answer sofar. I would appeciate your answer to these two questions, please.

    Yours sincerely,

    Gerry Stolwyk

    +++++++++++++++++++++++++

    7 July:

    Dear Sir/Madam,

    ERS--FAST TRACK,

    CMQ made a reference to FDA Fast Track on 4 Sept. 2001.

    I would appeciate if you could answer the following questions:

    1.I thought that ERS would have been granted some time ago. When do you think it will take place.

    2. With- and without ERS, when do you expect Full FDA approval to be granted.

    3. Do you think that some Announcement re progress on these matters is desirable.

    4. Are US animal trials needed to get that approval.

    5. Once approval is obtained, will the US allow the use of the drug for animals in the US.

    Yours sincerely,

    Gerry Stolwyk

    ++++++++++++++++++++++++++++++++++++++
    ++++++++++++++++++++++++++++++

    * * * Answers from CMQ:

    "Dear Gerry

    The FDA have granted Chemeq expedited review status.

    The rate determining step for FDA approval is that we are required to perform a final test with US pigs, on US soil, using material from our manufacturing plant. Thus, we cannot achieve FDA approval until our manufacturing facility is complete.

    Whilst we cannot guarantee timelines, we would expect FDA approval within approximately 6 months of commissioning of our manufacturing facility.

    Please note, that for sales and revenue purposes, Chemeq is not reliant on FDA approval for its revenue. It is only one country, and we will already be selling into other countries".

    Regards

    Andrew Dwyer
 
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