Paradigmers, tonight as we wait for some more news and the coast is quiet...let me indulge by presenting some analysis on The Fast Track System by the FDA and how it pertains to us.
What is the Fast Track in regards to Phase 3 trials? It's a "Process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need".
Started in 1988 is done in conjunction with a Investigational New Drug (IND). Generally it should attempt to meet some un-met need and/or be superior to whats currently in the market.We are very lucky to be able to utilise this process as we are fundamentally dealing with a drug that has already been on the market for decades, this effectively saves us a whole heap of time in terms of the approval and pathway to commercialisation. That, coupled with the fact that we have real world evidence with the TGA SAS trials, makes for an expedited process to hopefully, result in commercial success and a respective share price!
PROCESS
Apply and it takes up to 60 calendar days to get a decision as to eligibility. In 1992 the FDA introduced two more review processes namely Priority review and Accelerated Review.Priority review can result in drugs being approved within 6 months instead of approx 10 months based on the efficiency.A fast Track process involves more communication by each party (Between applying company and FDA) as well as the ability for Rolling reviews, eg no need to submit one set of docs and then wait for the result before submitting next set etc.
2 ADVANTAGES
Time, Money and Effort.
Time, can save around an average of 6 months.
Money, less costly as less number of patients potentially involved (hundreds instead of thousands for example).In PAR's case we are looking like something around 500 patients as opposed to the usual 1000 plus.
This results in a lot less effort, particularly important when we have a skeleton staff and are mindful of expenses of the same. MPS In terms of the MPS strategy,"while a standard 505(b)(1) New Drug Application (NDA) generally requires two phase III trials (an initial pivotal trial and a confirmatory one), products being assessed under the 505(b)
3 pathway may only need one phase III trial. This difference alone could save the applicant several years and tens of millions of dollars during the product development phase of commercialisation and represents one of the real advantages of some drug repurposing projects."
3SUMMARY
We have an excellent chance of being 'awarded' Fast Track status, the previous competition, no longer an issue as the Phase 3 trials wernt successful for Tanezumab, was designated Fast Track as there is not only an acute need for an OA remedy but there is a need to stem the awful outbreak of drug related overdosing and harmful side effects in this area.The FDA has this in their minds.
Paradigmers, we should have multiple green lights at most intersections of the Phase 3 process at least it terms of the process, exciting times ahead? Most definitely. Stay patient do your own research and good luck to us investors!
Stay tuned for the next article coming to a Hot Copper screen soon, the next couple of topics I have planned are simply amazing and will blow your minds in regards to the potential of this wondrous company.
(1) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4936080/
(2) https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
(3) http://paradigmbiopharma.com/wp-content/uploads/2016/03/2015-11-30-Initiating-Coverage-Paradigm-Biopharma-Lodge-Partners-Final.pdf(4) https://www.spglobal.com/marketintelligence/en/news-insights/trending/bQfXMj2CB2HTWhHpLLvCeA2
(20min delay)