Ceviche, You are totally right to question where the spend is going, are we getting value for money...why have the timetables shifted, what if anything, can we do about it or is it all still heading in the right direction?
I'm not a spokesperson for the company. I have cash on the line like most on here...I do want it to do well, I forecast this happening but it doesn't mean that I can be blind to negatives or wastage (of time and money).
If I had to answer at least some of your concerns I would say this:
1) FDA have delayed us....by 7 months...what should've taken one month took 7 X Not fair...BUT they wanted to know more about a result in one of the many studies we did and there was some to'ing and fro'ing. This isn't necessarily atypical....
I do understand that this appears to have extended some of the timetables out by more than 7 months. How is this possible? Well there is some degree of conservatism built in, but also there have been slow downs and potential slow downs could come with some clinical centres being delayed or disrupted, possibly some transportation overheads in shipping the product around, these are only some examples I can think of, there could be others. (There are 3/4 of a million active cases of Covid now in Aus as an example of potential supply chain disruptions).
Consultants had to be employed, we needed the best advice and not only that, how do we present it? Redrafting of at least some of that 30,000 pages would've had some additional costs. We dont have the staff to be able to re-jig this...it had to be outsourced, more expense.
2) 008 has been implemented and adapted...there are now two centres and the program has had a 12 month extension study built in. More costs...but this is a key program and will potentially lead to a much greater valuation and revenue stream for us. There was a delay in-between as ethics had to be reworked, permissions sought, protocols to trial design changed...new clinic set up. Time and some extra cash burn.
3) Other studies, while not too dilutive in terms of dollars, they still add up...ARDS....Heart study...yes pre clinical models, they still involved some expenses no doubt. Increasing the pipeline increases our valuation to a big Pharma. Important we don't rely on just ONE or two indications...we want to show that we are here for the future, we aren't a one hit wonder. Our drug is versatile and proves the said MOA.
4) As we know after the PRE IND and the TYPE C, the FDA together with PAR came to the conclusion that the number of patients should be increased. This easily blows the budget... Again, we cannot argue via a TYPE A, no point in fighting the FED...FDA.
5) We have also added to the team, also just look at all the parties involved in vetting, screening and setting up these sites. Employing the top PI's in each area.
We are working with the EMA and FDA and ANVISA along with the TGA to formulate one of the most pivotal and comprehensive trials (OA and MPS).
Now you can argue like a few others saying Mozz...why do we need to spend and invest so much time and money at this early stage when money is limited and precious and we don't have a deal to cover our a88es..why don't we just do the one required trial plus the one confirmatory trial and push it through in such a shorter amount of time.
Mate, sure we can...
Let me assure you, it wouldn't be 3 plus years then, it'd be a heck of a lot quicker...BUT..at Registration time the FDA are going to say to us...YEP PAR, well done, congrats, you got thru, your data is half decent...here is a narrow label for you...and PAR, what do you think about how long the drug lasts?
Err sorry? What do you mean....
The FDA will ask us now where is our durability study....if there isnt one done, you can prescribe the drug but the label will restrict you. What then about retreatment? Is it safe? Think you need to go back to the drawing board PAR peoples....and please don't start selling it just yet....
We do not want this situation...we have to spend now to get these studies underway and to try and do as much prep and planning and testing as we can beforehand so that when we get registration, we have the answers to the above...
I fully understand it is frustrating when we are playing a game of footy, we have paid our membership fees, we got our footy gear on...we expect a great game...and half way thru the Umps are changing the goals? Making it harder and longer to score...no fair...how is this Footy?
BUT...for the longer term investor, mate we are preparing for the worst...we are building up to our label..its going to be so lucrative (my views), it will be broad based and the insurers are going to fall over themselves to sign us up...dont forget there are some 900 of these insurers in the USA alone...how do we attract them? How then do we convince the Doc's that this is going to be the NEW gold standard...this drug really works..AND there is proof of other joints (010 Hip for example) that they can prescribe for....
Dont forget, we will need to show them that we aren't addictive we can be used for safe retreatment and what is the FDA and us recommending as the average amount of safe time for this? What is the evidence...not just hearsay. Hard core data from a P3.
BY PROVING WHAT WE HAVE IS VERSATILE...is a WORLD beater...IS SAFE....AND can do so much more than ANYONE ELSE...... durability safety functional and POTENTAIL REVERSAL OF PATHOPHYSIOLOGY of OA ....a regression of the disease at least in some instances.
IF it takes a few more million and a year or two more, despite this being arduous (I get that)...if you can bear to wait..it could be a MULTI blockbuster one day and you will be the owner.
Again, I'm not arguing with you, I also want my invested sweat dollars to be utilised efficiently. But there is more that meets the eye here, there is a lot happening in the background for the longer term....question yes, we need to, but also be open to the answers.
(20min delay)