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PolTREG and U.S. Subsidiary Immuthera Secure Positive FDA Opinion, Paving the Way for a Registrational Pre-Symptomatic Type 1 Diabetes Trial
PolTREG and U.S. Subsidiary Immuthera Secure Positive FDA Opinion, Paving the Way for a Registrational Pre-Symptomatic Type 1 Diabetes Trial FDA agreed that PolTREG’s clinical data in Stage 3 Type 1 Diabetes (T1D) appears sufficient to support the Prospect of Direct benefit in an adaptive Phase 2/3 study of PTG-007 in Stage 1 and Stage 2 Presymptomatic T1D patients. The FDA is receptive to the inclusion of Stage 1 Polish patients in the trial’s statistical analyses FDA may consider the adaptive
About this update from Poltreg Spolka Akcyjna
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