RCE recce pharmaceuticals ltd

Ann: Update on Phase I/II Clinical Trial for Burn Wound Infection, page-81

  1. 5,505 Posts.
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    Hi.
    I believe Paradigm Pharmaceuticals just applied for IND and got approval at phase 3 see below, having just completed trials up to phase 2 in Australia without IND approval.
    This shows it can be done if nothing else.

    I guess it could prove to be costly as FDA will thoroughly vet any pre application data and request more tests or more in depth data if required. That being said the point of the FDA fasttrack approval that RCE already have is that Rce can discuss requirements for data presentation of IND with FDA and they are obliged to reply in 30 days. This and the fact they are using CMAX labs and paraxcel for upcoming iv trial makes me think they are definately pursuing FDA approval. I appreciate you want to bring a balanced argument to this forum but your suggestion that anyone wanting to seek IND approval should do so at the start of trials is just misleading I believe. It is well known medical costs in USA are astronomical compared to the rest of the world. Common sense seems to suggest if there is a legitimate path that can be taken to produce results acceptable to FDA then why wouldn't you.

    https://www.google.com/amp/s/www.*.com.au/companies/amp/news/965071


    Paradigm Biopharmaceuticals receives US FDA clearance to begin Phase 3 clinical trial for knee osteoarthritis treatment

 
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