Moleculin Biotech (MBRX) Receives Positive FDA Guidance Regarding Annamycin IND Submission

November 17, 2016 7:31 AM EST

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Moleculin Biotech, Inc., (Nasdaq: MBRX) announced it has received verbal positive guidance from the FDA regarding its planned IND submission indicating that the Company may incorporate by reference the IND established by a prior developer.

Moleculin's Chairman and CEO, Walter Klemp, commented, "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. On our current path, we expect to be able to file our IND submission before year end. Barring a negative surprise from the FDA's review of our submission, that should allow us to begin treating patients in our next clinical trial several months sooner than expected."

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. The FDA recently indicated in writing that it intends to provide written responses to the Company by December 6, 2016 and that it does not believe a live meeting is necessary. Once those written responses are received, the Company will adjust its final IND submission document accordingly and submit for final FDA review. IND submissions are normally reviewed within 30 days of filing.

The beginning of the Company's next clinical trial for Annamycin will depend on many things, including but not limited to the absence of any objections by the FDA to the Company's IND submission, review and approval by an appropriate Institutional Review Board (IRB) representing the proposed clinical site or sites, and the ultimate recruitment of patients by qualified clinical testing sites.

Dr. Don Picker, Moleculin's COO added, "Based on this positive guidance, we have already begun discussions with suitable testing sites so that we can begin recruiting as soon as we have IRB approval. We intend to hit the ground running as soon as the IND is active."



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