Maz, good thoughts and I would add to your question about a CRL with some points to ponder...
Many have cited the FDA for being gutless and all too often the tool of big pharma. Yet, we know they are under pressure to address the opioid abuse problem and their new head indicated this was to be one of his major undertakings. With that as a backdrop, to date we have seen four ADF submissions for approval. One was rejected with a CRL - Kempharm, and two (PFE & Teva) were given ADCOMs. Only one company was given a Priority Review - Elite for SequestOx. The FDA decision to grant a priority review is, in itself, a decision that suggests confidence in approval; further evidence of that confidence was that Elite had no ADCOM. Even if we agree the FDA has been gutless and the tool of big pharma and wishes to continue down that path, why would they have given Elite a Priority Review and no ADCOM? An ADCOM would be the best way to deflect any criticism they might receive for not approving the first in class IR ADF. Moreover, if we consider what has been described as significant trial results (p<.001) and having passed every test tossed their way, it defies the evidence to suggest that anything but approval is awaiting SequestOx. That it is not apparent does not make it so. We on the outside are not privy to the facts at play inside the FDA and Elite. That is as it should be. Still, I see some suggestions that there should be greater transparency and communication by the FDA and/or Elite that defies business and governmental practices and borders on arguing they should commit violations of government administrative rules or even the law. Nonsense!
We will know when they want us to know, exactly what they want us to know.
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