Israeli cell therapy company Cellect Biotechnology (Nasdaq: APOP) has been given confidence in its ability to progress its goals rapidly by the US Food and Drug Administration’s (FDA) hiring of 50 new clinical reviewers who specialize in this area.
Chief executive Shai Yarkoni expects 2019 to be a significant year for Cellect and the progression of its global clinical development program.
He said: “I believe the special attention and resources being allocated by the FDA will allow us to further advance our cell therapy programs as we intend to submit an IND for a Phase I/II study in the USA and an IDE for our second product (the Apotainer) and complete the preclinical effort towards a third indication by the end of 2019."
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