Apologies, the editor went a bit crazy back there...
Huts - Thanks for your feedback -Yes it takes time anyway. Then add the fact that we have decided to pour more concrete onto our base for future expansion.
Speaking of pouring concrete , Chadstone Shopping Centre is purported to be the biggest shopping centres in the Southern Hemisphere. They have had numerous amounts of stage expansion of the years. Currently I find it remarkable that they have added extra levels of parking to two different car parks without having to deconstruct them.. Chadstone boasts around 11,000 car parks. Their numbers are increasing, the shopping Centre has its own hotel and now two separate 4 storied Office towers...they are building a nine storied office tower in addition!
Point of this? We too have expanded our base...making it stronger for future expansion and global sales potential.
From a single market to the inclusion of Europe, but no longer in tandem....simultaneously and harmonised with the gigantic US market. That's some effort to do that.
We have increased our sites from 65 to now 120.
We have also added countries such as Canada and UK
We have not only added a separate 008 program to illustrate DMOAD connotations as well as illuminating the link between synovium and serum, but we changed and improved this mid stream:
A- Two sites instead of one
B - 12 months instead of 6
C - Introduced third patient arm to incorporate another dosing frequency
Why did they do this? It wasn't random. It cost them money..it cost them resources...it cost them time.
Is this not manufacturing the golden key to entirely change materially the discussions with the authority? Just imagine that data pack that will get submitted! Now that would be one heck of a read...the MRI's...the individual wet biomarkers, the patient's stories via PGIC and Rescue Medication, all of the observables for linking what the patients are feeling with what's happening from the biological process prospect. What a book that will be...and then to be able to submit that to the FDA and later EMA? I have no words.
There are many other examples, another good one I like is the introduction of 010 - Hip study, linking multiple joints. This goes straight on to the label. Expand that label and you automatically broaden the patient volumes. Do that and we see a material increase in revenue. Don't forget, Docs are humans too, they will be conservative especially at the start and will strictly follow the medical associations guidance and what is on that label. Most of them do not have time to research for themselves what all these new drugs are! They will be guided.
Now multiply that last paragraph by the fact that we are doing RETREATMENT and DURATIONAL studies. How comprehensive are these programs?
Babba - A surprise for you for your excellent recall:
I still remember his look of wonderment and delight. He had the broadest smile of surprise and a mix of seriousness when he saw those MRI's. I caveated it by saying it is only one patient.
He simply said...
"Well, it all starts from just one patient".
Paradigmers, it all starts from just ONE patient. We have 800 plus through SAS
We have 10 American Ex Pro footballers
We have 117 x 4 in our Dosing Study that have just finished
We have 60 odd in our 008 that are almost done.
We have our fantastic two pronged MPS (I and VI) programs almost done
Bring it on!
(20min delay)