Jupiter Orphan Therapeutics, Inc. receives Safe to Proceed Letter from FDA!
This is a brief update on our IND, which was submitted to FDA in early March. The IND is required to be compliant with FDA guidance regarding clinical trials. The procedure for IND approval is that FDA reviews the IND contents including the proposed clinical work for a wide range of issues, everything from cmc documentation, preclinical work, and any preIND issues that are outstanding, as well as regulatory compliance. Proposed protocols are also reviewed. In our case, pre-IND discussion suggested that we "open" the IND with a PK study, which is what we proposed. After submission, FDA has 30 days to review the IND materials and proposed work, and if any issues cause FDA concern, they can issue a Clinical Hold - in which case IND work cannot proceed until the "hold" issue is resolved. If FDA does not place the proposed work on clinical hold, the work can proceed if one of 2 things happens; 1, FDA can inform the applicant that they can proceed; or 2 (more commonly), FDA does not communicate within the 30 day window, in which case the work can also proceed. JOT has received written communication from FDA that it is "safe to proceed" with our submitted clinical trial request. Specifically, this means the PK study can proceed. This is the best possible outcome of our IND submission, as no regulatory delays or hurdles have been imposed on our program. 
JOT Announces Submission of Investigational New Drug Application (IND) for Treatment of Mucopolysaccharidosis Type-I!
Jupiter Orphan Therapeutics in Process to Submit IND for MPSI and Other Indications!
JOT SAB Meeting at Harvard Faculty Club in Boston, Massachusetts. "Monumental Day" as David Sinclair described it! Review of existing and upcoming clinical programs as well as targeting of new indications.
JOT will be attending the FARA/FDA FA Patient Focused Drug Development Meeting on June 2 in Hyattsville, MD.
JOT's CEO, Christer Rosén, will be attending the 13th Annual BioExec Institute Retreat on March 29-April 1 in Palm Beach, FL!
Press Release: Catalent to develop softgel capsules for JOT's leading orphan disease candidates!
Read article here! 
Press Release: Professor Li-Huei Tsai, Ph.D., Professor Scott Turner, Ph.D., and Robert Hahl, Ph.D. join JOT!
CEO Christer Rosén will be attending the 2016 Boston CEO Conference May 31-June 1, 2016
Press Release: David Sinclair, Ph.D. joins JOT
FARA includes JOT101 on their FA Treatment Pipeline - January 2016.
JOT initiates collaboration with the Friedreich's Ataxia Research Alliance (FARA).
JOT participated in the 2016 Noble Financial Conference in Port St. Lucie, FL, USA.
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Jupiter Orphan Therapeutics to present at the World Orphan Congress!
Christer Rosén, Chief Executive Officer, will present at the World Orphan Drug Congress in Gaylord, MD on Thursday, April 26, 2018 at 12:50 pm ET. 
JOT receives Orphan Drug Designation for its trans-resveratrol product JOTROL™ for treatment of Friedreich's Ataxia!
Press Release: Jupiter Orphan Therapeutics Secures Financing and Adds Board Member!
Read article here! 
Jupiter Orphan Therapeutics, Inc featured in Wall Street Journal!
Press Release: JOT enters into a Global Licensing Agreement with Murdoch Childrens Research Institute for development of treatment for Friedreich's Ataxia!
JOT launches Facebook and Twitter pages! Go in and follow @JupiterOrphan and like our Facebook page!
JOT moves domicile to Delaware on January 1, 2016 with operations in Jupiter, FL.
Cooley, LLP engaged as corporate council.
JOT participated in the November 2015 NJ/NYC CEO Biotech Conference in New York, NY, USA.
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