I particularly like the time from IND submission to starting the Trial Program...30 DAYS!!! Glad I loaded up this week!
"The IND submission includes a comprehensive package of data, encompassing preclinical pharmacology and toxicity, manufacturing, quality control and clinical development plans. Novogen will be able to move forward to the next step of setting up the clinical trials program thirty days after submission, unless FDA reviewers have questions or concerns which cannot be resolved during that time.
Dr Kimberley Lilischkis, Director of Clinical & Regulatory Affairs at Novogen, commented, "the Cantrixil IND is a critical step on the path to the clinic. We will work closely with the FDA to resolve any queries they may have. Following that, we expect to initiate the study swiftly in the last quarter of 2016, with participation from centres in the US and Australia." "
NRT Price at posting:
9.2¢ Sentiment: Buy Disclosure: Held
