Moleculin Receives Postive FDA Guidance for Annamycin IND

Moleculin Biotech (NASDAQ:MBRX) today announces that it has received positive guidance from the FDA for its upcoming IND submission.
According to the press release:

“The Company has indicated in previous disclosures that it expected to begin its next clinical trial by the first half of 2017, however this development may reduce that time frame by several months. The Company has submitted a pre-IND briefing document to the FDA along with key questions regarding its clinical development plan and a request for a meeting, if the FDA deems it necessary.”

CEO Walter Klemp said the following:

“This new positive guidance removes a major question mark and allows us to create a tighter timeline for the estimated beginning of our next clinical trial. To be clear, we still can’t rule out the possibility of a delay in the timeline, but with the knowledge that the FDA is encouraging us to simply incorporate by reference the prior developer’s IND, we believe we can accelerate our IND submission process.”

Read the full press release here.