NEW HOPE, Pa.--(BUSINESS WIRE)--Protalex, Inc. (OTCBB: PRTX) today announced that it has received preliminary feedback from the U.S. Food and Drug Administration (FDA) expressing concern related to data on certain subjects who participated in its Phase I safety study for PRTX-100. Based on this feedback, Protalex will conduct additional analyses of data from the Phase I clinical trial. Consequently, the submission of an Investigative New Drug Application (IND) in Idiopathic Thrombocytopenic Purpura (ITP), initially planned for the fourth quarter of this year, will be delayed.
