Looks like we on the move, page-61

hi eweezy,

finally tried getting around to reading the below tonight... only half way through and the bed is calling...

	Date	Source	Title	Access
1	5 May 2019	Hitanshu Dhingra, Adelaide Equity & Partners Ltd	A deep dive into Paradigm's OA program and partnering prospects	Download PDF

below are a couple of great comments/quotes/illustrations of FDA fast tracking:


"All of this should not come as a surprise given the FDA’s view towards this class of drugs and multiple occasions where anti-NGF clinical trials have reported AEs. Despite this the FDA granted Tanezumab Fast-Track status in 2017, most likely due to the Opioid Epidemic prompting the regulator to consider other non-addictive pain treatments."

"Of particular relevance is the recent approval of Spravato (J&J) which is S-antinomer for well-known anaesthetic Ketamine – this is similar to repurposing, but not via the 505(b)(2) pathway. Spravato was approved by the FDA on just a single positive placebo-controlled trial (there were a number of earliertrials that did not prove efficacy). In the committee review that discussed the approval of Spravato, the FDA highlighted the un-met need for new depression drugs, that no new depression drug has been approved for 30 years, the side effects of existing depression drugs and willingness of patients to try new treatments."

Definitely a good read so far, and recommend to all holders or possible holders...

https://paradigmbiopharma.com/wp-co...maceuticals-Ltd-ASX.PAR-Wholesale-SI-Note.pdf