HGR unknown

worth 1 dollar on fda approval, page-16

  1. 13,866 Posts.
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    More misinformation - like about 50% of the posts on this thread. People are too lazy to research properly and love sounding like experts. The facts:

    1. As already announced by the company filking for FDA approval is anticipated by the end of the month (ie tomorrow). Will they be on time? Maybe. Maybe not. But all resources have been focussed on this (also documented) so should not bee too late, if at all.

    2. The FDA has a statutory MAXIMUM of 90 days to assess applications. Most times it is well less than that. In this case, because of considerable liaison that has already occured between HGR and FDA, and the fact that Oraline 4 was pulled from the market, it will likely be within 30 days. The managing director has said as much to me directly. So FDA approval should be through by early October.

    Would be good to see more research and less hype and BS.
 
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