PAR 2.04% 24.0¢ paradigm biopharmaceuticals limited..

Ann: IND QUESTIONS RECEIVED FROM US FDA, page-235

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  1. 142 Posts.
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    Agreed dtcope. I have also out come up with three potential scenarios that might play out over the next week or so and probabilities based on what we know so far. Keen to hear anyone's thoughts.

    By Wednesday June 30th

    Scenario 1. Company announces that they have filed their response to the FDA's questions.
    Scenario 2. Company announces that they require more time to lodge their response to the questions.
    Scenario 3. No announcement is made.

    My probabilities

    Scenario 1. Response filed. Probability 70%. 30 day clocks starts ticking and we wait. As dtcope says there is still a chance that the FDA could still come back with a query if we dont quite "quash" the questions.

    Scenario 2 Need more time. Probability 20%. Company decides that they need more time to address the questions to get them 100% correct and would rather get an A+ than a B+ . They take the extra time to avoid another round of potential questions. This scenario might put some short term pressure on the SP.

    Scenario 3. No announcement is made. Probability 10%. Would indicate that the company is still working on the response. Probably not ideal for the SP. But still a possibility. Company would presumably have to indicate why it is taking so long to respond to low level complexity questions. Could be that the company has had some dialog with the agency and has received some additional direction.

    Regardless I am still a long term bull when it comes to PAR. Just like to think about the scenarios and probabilities whilst we wait

    What does everyone else think?

 
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