Ok, here's the progress made to date on NEU and what we can expect shortly...
* The IND for the mTBI (concussion) study is already opened.
* Because the IND is already open, initiation of the study requires Neuren to only submit the Investigator's Brochure and protocol to the FDA and IRBs.
See here for additional information on IB & Protocol - http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf
* The increased dose that Neuren used in Phase I appears to have caused the delay in starting up the mTBI trial.
* With the Phase I completed, Neuren are now finalizing the protocol and Investigator's Brochure for the mTBI trial as well as the Rett study.
* For the Rett study, Neuren had to wait for the final Phase I report to file the IND but stay tuned as Neuren should be updating us on this any moment now.
A little background on Mike Bickerdike from Neuren....
http://www.linkedin.com/in/mikebickerdike
My professional experience is in the research and development of new drugs for neurological and psychiatric conditions and diseases. I offer extensive knowledge of the drug development process from early stage concepts and preliminary testing through regulatory safety studies required to initiate clinical trials. This breadth of experience comes from a solid research base, coupled with considerable experience of research project management, collaborations management and preclinical development leadership. I have overseen the progression of several novel compounds from early stage research successfully through to clinical trial testing. A further aspect of my current role is preclinical support of ongoing clinical development projects, through the provision of Investigator's Drug Brochures and IND submissions to the FDA.
