Mozz's notes from today's call:
Others, please add to anything I've missed
Apparently the call is recorded and to those that havent heard it live, it will be worth listening to it. The extra detail from Pre IND meeting is very interesting.
Some key highlights for me were:
1) There were three key parts to the FDA Pre IND meeting:
A) Agency asks PAR q's about study and adta material
B) CMC Manufacturing of API and Product
C) Questions by PAR to FDA
A) There wer every few questions from FDA, safety has been established
B) There were no questions about the Bene API
and no questions about GMP.
C) FDA reiterated that all samples for Phase 3 must be the Bene formula, ie same structure and moiety batch to batch. Same certificate of analysis must be used.
2) Paul clearly stated that there are now patents in force in USA, AUS, China, Japan, Europe
3) Generic competition is no issue. It is extremely hard to reproduce the exact moiety and structure batch to batch.
Paul state that he believes we have a 10 - 15 year head start because of this in terms of generic competition.
Evidence is Johnson and Johnson (Janssen) - Elmiron - being off patent since 2010 and there is still no generic competition.
4) Good news from Pre IND in that we will have the SAME PRIMARY and SECONDARY points as Phase 2. What does this mean?
Quite simply this means that our Phase 3 will essentially be the same as Phase 2 just with larger numbers! (Mozz notes:This was a big hurdle in my mind that we crossed. and saves a lot of headache and time in terms of design and coming up with suitable endpoints acceptable to FDA)
5) Duration of effect. FDA has noted and acknowledged that our duration is 12 months.
More good news here, the FDA actually discussed a future consideration namely the labelling and they even mentioned that on our future label we may add the that this drug (iPPS) has a 12 month effect! ie this drug should be re-administered after 12 months. (Mozz notes
aradigmers this statement from the FDA has a lot of significance to us in terms of our drug's potential and uptake from the consumer and docs. It's a key statement.)
6) Our results that we achieved so far from latest SAS batch is based on just 35 subjects. We are comparable AFTER 6 weeks..ie no drug is left in the patient compared to TRAMADOL used on a daily basis (and was used on he day of the test). We are in fact better (in terms of pain reduction experienced) to low dose Tramadol.
7) CSO working on the second publication to be submitted for Peer review
8) More info (% and numbers) on Drug effect to be published.
9) Paul's mentioned with fully funding we are in a better position now for a share re rating in the future..no funding gap now in light of increased trail numbers.
10) Agency were impressed with our Phase 2 trial data.
11) Bene relationship very strong with PAR.
12) Question about can potential patients go to the vets to get iPPS. This would constitute a serous breach and wouldn't be an issue according to Paul.
Clarity and certainty from FDA was really the good news here with quite a few other great points coming out of the meeting. From a commercial sense there are a number of bridges we have crossed to this point. It looks good in my opinion.
DYOR
...I was multitasking, something I am not very good at..listening to the call AND typing out notes...a dangerous thing to do.!
(20min delay)