Moleculin Biotech (MBRX) Receives Positive FDA Guidance Regarding Annamycin IND Submission
- Top 10 News for 12/2: Crude Rips on OPEC Cut; Starbucks' Schultz Steps Down; Nonfarm Payrolls Flat in Nov.
- Unemployment Rate Drops to 4.6%
- Bond yields slip on U.S. jobs data, euro steady before Italy vote
- Alibaba (BABA) Founder Jack Ma Discuss Plans to Retire; 'I Don't Want to Die at the Office'
- Starbucks Coffee (SBUX) CEO Howard Schultz to Step Down, Appointed Executive Chairman; Kevin Johnson New CEO
Find out which companies are about to raise their dividend well before the news hits the Street with StreetInsider.com's Dividend Insider Elite. Sign-up for a FREE trial here.
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."
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Shire's (SHPG) Phase 3 Investigational Study of VONVENDI Meets Primary Endpoint in Controlling Bleeding in Adults with VWD
- GlaxoSmithKline (GSK) Announces Filing Regulatory Submission with EMA for FF/UMEC/VI as COPD Treatment
- Franklin Street Properties (FSP) Acquires Denver-Located Dominion Towers
Create E-mail Alert Related CategoriesCorporate News, FDA, Management Comments
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!