If that is , so then their April update is way off the mark. It’s my understanding DCGI approval is dependent upon their physical plant meeting standards and being operational for local production. I don’t see where the IDE submission package would be dependent on DCGI approval or any benefit to waiting until after DCGI approval.
“ We remain highly confident in the quality and completeness of our application and anticipate submitting in the near term with no substantial delay expected. This submission represents a critical milestone that significantly de-risks the program andpositions RadioGel® strongly for a successful IDE review and advancement into human studies. We will provide a further update promptly upon submission.”
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