DOGS:
16 dogs completed the trail with optimal dose and have completed bloods
- - 9 dogs hit RECIST (stable disease)
- - 7 did not
9 dogs completed the trail with optimal dose and have NOT completed bloods
- - Most are unlikely to improve the situation for RECIST (stable disease) as Kim said, from his memory, they are all progressive disease dogs
5 dogs were sub-optimal dose so they will not progress further
4 dogs started but were removed for a variety of reasons.
So, the objective was to get to 18 dogs with SD and optimal dose. There are 21 more dogs in the available cohort to hit this target.
We need 9 more
IFthe clinical end point remains the only objective to fixate on.
To sum this up and counting down from 34 dogs:
34 minus 4 > removed from trial (for whatever reason in the early days of the trial)
30 minus 5 > removed due to did not strictly follow protocol etc (owner o treating vet)
~~~~~~~~~~~~~~~~ Assume only the below 25 count as on trail to make up the available 48 dogs ~~~~~~~~~~~~
25 minus 16 > that are DONE
>> 9 are RECIST and 7 not
9 remaining waiting on bloods as mentioned above where Kim has set expectations.
.......
So 25 dogs on trial, and 46 - 25 = 21 more can be added to the trial.
Easy, right
Why is the bloods taking sooo long for the bloods:
- - The lab for the testing moved from QLD to VIC. Also NZ were very slow at sending bloods for testing. Put all that together with custody chain etc, it just takes time and some of these things are clearly out of the control of the company.
I hear you ask, so why are the 9 dogs that are incomplete not likely to help the target RECIST (SD).
- - When the dogs were recruited, some vets brought on dogs that had more advanced disease.Kim has been addressing this and looking to get early stage as the sooner they can be on MPL, the probability of SD improves.
So what, this just means it is going to take another freaking few years?? you ask. Well, you could be pessimistic and make that assertion.
- - My take is, they have more sites, they have more informed position and we have more evidence of efficacy. The argument to give the MPL thing a crack is becoming compelling.
But Stable Disease is so important (SD), right?
- - Well, maybe not. This bit really hit me. The median overall survival time is about 150 days, regardless of Progressive Disease (PD) or Stable Disease
So what? The trial is being measured on SD and 18 dogs, isn't it?
- - Well yes, and maybe not. The clinical trail is certainly having that target but the more learnt, we can let the data and science determine how it influences commercials.
Will they keep going to MPL only or will it do combo?
- - no change to Ph2b (+). it is 28 days of straight MPL, then the vets and owners can choose their journey from there and Pharmaust is highly interested in their journey as every little data point helps
So show me the money! When will the trial finish?
- - How long is a piece of string? It comes down to the RIGHT DOGS at the RIGHT phase of disease joining the trial. We have more sites so one would hope we could get this moving a little quicker. But it will take a little time.
Who is global pharma and what about Elanco?
- - Elanco and Pharmaust have had communications so that is not a write off. My take was there were others in the mix too which is fantastic to hear.
Enough of "we are talking" and how about something more tangible: Roger said the discussions are very well advanced and the rest is commecially sensitive. Ok, so as much as i want the nuts and bolts, it is not something they will spill the beans on.
Is the deal going to happen for Phase 3?
- - Maybe and could also happen any time prior. They clearly stated that if a reasonable offer presented that PharmAust would take a serious position to confirm a commercial deal either prior to completion, during completion or post completion of Ph2b(+) as we move into Phase 3.
WIll this lead to a credit raise ?
- - THe Phase 3 will cost but it comes down to where that money will come from. Ideal and what they are working towards is that money coming from a deal to cover Ph3.
How valuable is it looking:
- - They are really finding the niche and that argument is getting more compelling. Have a look at the slides (8). CHOP is nasty but gives more time. then the other 2 main options are also nasty and give far less likely time. The MPL has a sweet spot closer to CHOP than the others but without the nasty and the hefty up front costs. If your dog hangs around you pay a smaller price over a longer period. If your dog sadly passes, your financial burden of treatment would be minimal. I think this would be very attractive in so may ways. The fact that SD and PH are giving similar survival and quality of life is just mind blowing.
One call out: between 60 and 80% of dogs are just put down rather than being treated. This is a HUGE opportunity if the vet market can see, like we can, that there is a viable and affordable option.
Ok, I think that is a wrap on dogs. post single, simple questions and i will try and answer - noting this is just my opinion and memory. If i got anything wrong, happy to be corrected.
Classic closing comment from Densy to me: The clinical end point of 18 dogs having stable disease by RECIST is about as important (commercially) as a dog being able to catch a stick. OVERALL SURVIVAL is the commercial argument and that argument is growing strongly. (words along those lines)
I will post on other aspects of PharmAust later.
adreamer (thanks QQ and Densy for your input)
(20min delay)