Oncolytics Biotech Inc T.ONC

Start of new week recap

[canadafan]

Sure has been some stuff pasted last few days.
im not involve or know either, don't take personal.
Notable does post a lot if stuff, with a lot 
All related somehow with Onc: in some cases requiring some thought to relate to the like.
Most of which are market/ drug/ value type of comparables.
seconded by related stories on various cancer & comparable cancer treatments.
My extraction from all that.
1. Pelareorep has shown excelent efficacy within the Pancreatic trial. 
2. Pelareorep requires very little special handling. Administration is a simple I.V.pelea finds the tumour. Meaning does not need to be injected directly into the cancer. Next to impossible with mutiple locations.
3. Many pharma deals, have been done lately. Paying Billions. More than one B. and, paying that for products with a lot less.

A lot less?
oncpytics biotech has two FDA fast track approvals for cancer treatment, they have been ramping up production in need for the phase 3 trials.
So all of that in general & sometimes broader sense from Notable. 
lots to read. I look deeper into the various presentations. Takes a bit of time.
Certainly deserves mor3 than the silly & variations conspiracy theories. Whic( have zero to d9 with anything. Other than your job of creating FUD & general noise in the site, what do you contribute. ZERO.
evrn if my or any post is infotmation  thst notable or others posted previous, lsat week.it still is valid read, for those who have not seen this yet.
moving in to this week ahead?
We still need update on $$$ source for phase 3. Roche being colborator in the 5 cohorts of the Goblet study, is most obvious canditaed for a business partner or buyout.

Same story for MBc , different business. opportunities. They havec listed as TBD.

[Quentin30]

Ramping up Production...??? Just remind us Canaduh, how many patients will be in Phase III trials in 2024..??  ONCY has determined that their product is stable when refrigerated for up to 10 years... They have so much stock, that they've been able to keep it on stability studies for a whole decade..!!  Also, doesn't this represent a potential headache for clinics

[Azzak34]

"Whilst the market in general raves ahead" There's one stock in particular that's getting wrecked.... I can't think of the name? Any ideas Quenty? 

[Hydroqc]

I agree with you Quentin, it doesn't make sense to ramp up production for a phase III trial. But it would make sense for an accelarated approval phase IV confirmatory trial.

[CMHarring218431]

Although, your comments are meant to be negative.....perhaps your analysis accidentally, hints at a much more desirable outcome. Comments? is it possible?

[Hydroqc]

There is no negative in my comment. Sarcasm over Quen yes. He just made me ask myself, why would they ramp up production for 300 - 400 patients since they would have enough doses already.. The only answer came easy. Accelarated approval phase IV confirmatory trial.

[lonc17]

Hydroqc, That's exactly what ONC wants you to think.  It's very likely just another tactic to generate interest and feed demand for the ATM. Kudos to ONC for keeping the pump and dump scheme rolling. 

[Azzak34]

Another great point Ionc17. Ramp up production so that we all think they may actually need additional doses of Pela for some reason.... and it's all chicanery!! There really is no chance of getting anything past you.  I bet you were a big murder she wrote fan and worked out the killer within the first few scenes. It's impressive. 

[lonc17]

"Ramping up production" and "Talking about ramping up production" are two very different things. ONC can dedicate 25% of its year end conference call taking about a ramp up of production without having to spend a nickel. And then it becomes a meme (they hope).

[Peladawn]

It would also make sense for beginning to roll out sales, once accelerated approval is granted, and the innevetible, subsequent buyout is announced, of thousands of doses to oncology specialists worldwide, and their long-suffering desperate patients who have been waiting for what seem like an eternity to finally be given some real hope.

[ENEMENEMYNEMO]

Yeah waiting for 20 years and counting right CF?

[inthno]

Most likely but not for sure is that AA is not yet in the cards and we would have been granted that by now. As for the ramp up in production, it does eventually make sense especially if they are going into a phase 3 or possibly 2 phase 3 trials plus the folfirinox pela trial and the scaa expansion trial which has already started. They have always stated that they have enough supply to get them

[Noteable]

A scaled-up and validated manufacturing process that addresses the security of product supply and global regulatory requirements, for example, has now prepared pelareorep for both the FDA and EMA to grant Accelerated Approval, respectively.

[ENEMENEMYNEMO]

(TSX:ONC) today announced that, following submission to the U.S. Food and Drug Administration (“FDA”) for review, the Investigational New Drug Application containing the protocol titled “A Phase Ib study of pembrolizumab (KEYTRUDA®) in combination with REOLYSIN® (pelareorep) and chemotherapy in patients with advanced pancreatic adenocarcinoma” is now active. 

[Noteable]

Since the Phase 1b pancreatic cancer study involving Keytruda, which required ONCY to purchase Keytruda from Merck at full retail cost, ONCY went on to develop a supply agreement with Roche,  which was a normal agreement where both parties supplied each other's product, atezolizumab from Roche and pelareorep from ONCY at no cost, in pursuit of a common clinical trial goal, which began

[ENEMENEMYNEMO]

Oh sorry...my bad...that was a story from 2015!!!! Gee not much has changed in 9+ years has it???  ONC must be the longest string along in history. 20 years of multiple Ph I,II &III studies and absolutely zero to show for it. You got to give the management team some credit here....WOW...I mean they should start selling some bridges as a side gig. 

[ENEMENEMYNEMO]

Hey Note...check this one out...2007 whoo...they must have forgotten how to make this stuff...silly Matt! Oncolytics Biotech Completes Initial Scale-Up of Manufacturing Process for Reolysin   April 30, 2007     40-L batch size achieved for this potential

[itntdf]

enemenemynemoron, when a company has a production capability of producing 40 litre batches and then ramps up to a 200 litre batch, that would be considered a major change.  that requires fda approval. A major change is a change that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product as these factors may relate

[ENEMENEMYNEMO]

Haha. 40L to 200L is a few weeks work at best not 16 years.  Your logic is nonsensical.  

[inthno]

From a 2011 investor presentation which shows then that the company was producing at 100 litre batches for years. And the company always stated each year that they had ample supply for all the upcoming trials so hopefully the change from 100 to 200 litre formulation is indeed for the specific purpose of commercial production which makes sense if the company is in negotiations right now

[ENEMENEMYNEMO]

Producing "more" is not a change to the drug itself, what you quote is irrelevant to quantity produced unless production protocols change. 

[Noteable]

EniMiniMyniMo . .stupid be as "stupid yoh"

[ENEMENEMYNEMO]

You are bullying me... please my pronoun is "Mo"

[Quentin30]

NO it is not a major change... and FDA need only be notified IF the product is approved... even then, a batch size scale up less than 10 fold is considered minor... so could be submitted as an annual reportable change or CBE-0, NOT a prior approval supplement...

[Noteable]

Consequently,  200-L batch size fills would result in increased total yields of at least 100,000 doses at the maximum clinical dose for intravenous use versus 20,000 doses at 40-L which translates into a 5 fold increase in scale-up.   The size and capacity of bioreactors can be different. However, 1000 litres is usually the maximum capacity of a bioreactor used in any