The Buck...Some good questions raised here.Let's take a look at...

The Buck...
Some good questions raised here.
Let's take a look at a few of them:


ORDER OF EVENTS

Before anything we need to find out what the costs of the P3 is going to be.
Working backwards, we need to have all of these Q and A sessions out of the way. No one, and I mean no one knows how many more rounds (if any?) there could be...reminds me of a boxing match of sorts..


_{Fda? Bring on Phase 3/Round 3?}



At the end of the day...we are at the mercy of the FDA. They will have a good sense of what our data is saying so that's a good thing to have in our corner. They will also get a sense of what the effect sizes are and the safety profile. This is assisted by all the 006 data, the 005 and the sterling 008 data...the boxing coaches (KOL's/Consultants/CSO/CMO/PI's/Bio Statistician) are all guiding us to win...



Once we get that feedback we will not only know the final n (for 002 stage 2 and 003) but we will know other parameters like confirmation of endpoints and the big one, monitoring conditions required. Once those are all sorted THEN we can work out what funding options might be on the table.

Par no doubt would have already started garnering ideas and thoughts about where funding can come from based on scenarios.



DO WE MAKE EVERY EFFORT TO LIMIT COSTS?

Well from my view, it's a resounding yes. They have slowed/stopped all other programs to give our OA program full priority. They are watching every dollar carefully. They are cognisant of DM in the background but it is getting the drug to market sooner by Pain/Function endpoints that is top of mind. Revenue is king...


DO WE PUT TOO MUCH EMPHASIS ON THE FDA?

No...we can't give enough emphasis on this. Its the number 1...its harmonsied with EMA...Canada and Aus would also be tied up closely with the final result (despite TGA separate app. chances). Breaking this harmony is always possible but thats last resort kinda talk. They wouldn't do that...better to persist with FDA...its really a Global opportunity once you have it sanctioned with the FDA/EMA. Even the massive, and I mean massive market of China is linked here.


REAL WORLD INFO

Yes understand your point, but it gets covered off in that last paragraph. We already have some really lovely RW data...think SAS...think PGIC...think EMA (albeit n=10) but there are many others....for example...Rescue Medication...that was amazing good data for the authorities...it really does display our drugs effect in real terms from the patient's perspective, PGIC measures.


DO WE NEED BP/MP FUNDING?

Yeah this is one I'm still chewing the fat on. I want BP/MP to now pay for their dilly dallying...of course it's not entirely their fault, they are waiting for our great data but with a higher n. Its not everyday some Austrian? Australian? South Pac drug company with a staff of how many? 21? Is that thousands? Claims they have a drug that has NO serious AE's, stable at room temperature and can produce HWHA naturally from within cells? Cartilage Volume increase what? BMEL rapid reduction who? Baloney, give me a P3 then I'll believe you and put money where me mouth is.

The time to pick up a deal on us cheaply has passed...now they will need to pay more. (Totally my views)

Yes we need the money...the funding...but I believe there are viable options that are non dilutive...again, need to work out first what are our actual costs, this should be known within a few months time Im guessing.


CAN WE BRING THIS TO MARKET WITHOUT BP/MP?

Unlikely...at some point we will need them...we certainly cannot roll out a huge staff force on our own..no way...it would take not years but decades...we will partner up with an established partner that has the right channels in place. This is the way to achieve the literal millions and billions in sales at a very fast and steep clip.

I do hope we get a region to ourselves, eg Aus/NZ. It would be so lucrative and so wonderful to have a major revenue stream where there are little to no royalties payable. Even here we might partner up with a purely logistical type partner but I think we'd keep the vast majority of revenue to ourselves in this area. Its complex though, what do we do about marketing and labeling? There would be a disparity/difference between the ROW...how would that work? What happens when we start adding indications to our label? Would there be different formulations for different indications? How would that synch with the rest of the Globe? There is merit to consistent messaging..



_{Right...let's do this...}


Lots to think about. At the end of the day if we don't get a region exclusive to us, I don't see it being the end of the world, we'll hopefully be just too darned distracted with how the sales are coming in and what indeed the patients are reporting...and lining up after their cousin/neighbour/aunt took the drug and the results are astounding. Is this far away? Maybe only a few years...



^{When can we see the above? We will be so distracted, will we care about who has exclusivity and what things might be like if we had just one region to ourselves??}




BENE

Ahhh Bene...I would love to go on and on about these dudes...they are our ace partner...yes there are real merits of forming even closer ties with these super guys...we already have a sterling relationship and it needs to be fostered. Can't say enough about how valuable they are to us and no doubt the reverse is true...


FINANCE

Yeah you are right, finance is all that matters..the drug works, the science is top notch, the safety profile in intact and there is such a broad application of the drug that its bordering on really silly...but we need stepping stones to understand what finance we need, how much, what quality of finance and what's available and that will drive us to fund the last important pivotal trial before we finally enter the pearly gates of revenue.










My thoughts