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The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post. Both documents note that FDA may request that the sponsor submit the DMC charter to FDA for review before the performance of any interim analyses, and ideally before the initiation of the trial.
This Assessment does not itself prescribe specific remedies for the ills it diagnoses; those are supposedly coming in the future Strategy document. The Assessment states that this prescribing is tantamount to doing direct harm, given the known and unknown risks and benefits of drugs in these contexts of use.
I started speaking about the connection our stool testing showed between Blasto and Hashimoto’s in 2014, wrote a comprehensive blog about it in 2015, and shared my findings with my Thyroid Mastermind colleagues. 2] So what do these various findings and patterns tell us?
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