Weekend updates & thanks to notable Hello all
first , my hats off to notable.He/ she has put out a lot of effort to detail the various advantages & applications of Pelareorep. That being clinical information as to why & how Pela works & why better co- therapy with some drugs & not others.
As always, i direct readers to the oncolyitics biotech web site.
They have a great presentation designed to " try" to explain the various in- place proven results & a focus to the future opportunities.
i say " try"
Cancer is a very complicated disease. Almost every type, has sub types.
and
our bodies react differently to treatments. Simply put not all drugs/ therapies work for everyone.
So just for starters , we have a very complex disease, then add in unlimited variables with the patients.
Leaving drug developments with unimaginable complex outcomes.
Drug companies after getting approval, need to market, manufacture & distribute product XYZ.
Pelareorep has full scale in- place approved production capacity.
The production cost is minimal.
Where the cost is , getting to the approval.
Right now, Onc has fast track designation for Pelareorep to be used for Pancreatic cancer & one type of breast cancer.
They do not yet have marketing approval.
The recent news release clearly indicates they are in- process of defining & starting a potential enabling study, with accelerated approval indications.
What does that mean?
First, understand ALL of ONCs activities are moderated alongside the FDA.
The pancreatic cancer trials are alongside Roche.
Those who enjoy bashing mangemet need to please inform Roche of your extream intelligence, as they obviously missed something?
Respectfully , Roche would not risk their good name , or their lead cancer product alongside oncolytics without massive due diligence.
Then again the upcoming additional arm added to the Gobblet studies ( G.I. Cancers), was the direct result of a competive application.
From that Onc was granted $5million,
moving forward the upcoming enabling study will be managed by CGAR, a global pancreatic cancer agency.
what does accelerated approval mean?
Once the studies are started, They can use previous study data & if certain milestones met, product approval can be granted, prior to completion.
Saving years of study time & obviously $$$$.
simple put, Onc is we'll set to move forward.
yes they still need a $$ partner for the MBc trial.
or a complete buyout.
Shareholder value? As notable pointed out the company that just did a pharma deal with $850mill upfront, was not even a listed company.
The value is in the potential market of the product.
onc is a lot closer to that now than ever.
Slow, complex....absolutely.
should they get approved , yes $ billios
take care