PXS 3.57% 8.1¢ pharmaxis ltd

respone letter - i don't think it is a worry

  1. 66 Posts.
    Hi All,

    Received a response back on this.

    "The FDA inspected our facility and those of our
    contractors those people that do some routine testing for us after the product is manufactured. The FDA had a number of issues that we believed were satisfactorily resolved some weeks ago. The issues were minor and didnt relate to the integrity of the product or our manufacturing processes. It came as something of a surprise to us that the FDA still had some outstanding issues. At this time we do not know what these issues are but given that they were minor after the inspection I assume they are still minor, but we wont know until we have had some additional dialogue with the FDA. This seems to be the normal way the FDA conduct their business these days. They are contractually obligated to provide a complete response by a due date and if they havent completed their work, then they issue a letter such as the one we received on Christmas day. This means they have met their contractual obligation. They have provided a framework whereby Aridol can be approved so we just work through the issues as we would normally do. There is nothing unusual or negative about this. It just is. Until I know the extent of their issues and have had a dialogue with the service providers I dont know how long it will take the FDA to have the appropriate level of comfort. At this stage in the process I dont expect it will take long. Certainly weeks or months and certainly not years.

    We regard it as unusual that all three service providers had an issue and this also points to the issues being minor."

    I hope this clears peoples worries a little.


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