Oncolytics Biotech Inc T.ONC

Very I last few weeks, months

[canadafan]

Those who like to ramble on about, ONCs 20+ year history.
Please carry on, if that makes you happy.
Regrettably, because of the long history there is an undertone of negative emotion.
Assuming Onc was new shinny junior biotech, with all of the recent research, news, study results & $$ support from PanCan and now CGAR, the SP would be significantly higher.
The technical/ scientific reality is, the past number of years were required to get to this stage.
Over 1000 patients have been treated, tested with Pelareorep.
It is certainly known Pelareorep only multiplies in cancer cells.
In that knowledge, " safe & well tolerated".
Some enjoy lampooning thst phrase. Again, a very important and differentiated outcome.
Many standard chemo treatments are very toxic.
It took along time to determine Pelareorep, is best used as a co- therapy.
again, hence the Gobblet reults with Roche.
Some of the DNA technology being utilized as part of biomarker indetifiers , was not available ten years ago, let alone 20.
The so called immunotherapy, using viruses is in medical history terms, very new.
I appreciate the frustration. I'm down, however due to recent averaging , I'm not very far away.
saying that.
My " investment" with Onc is still the same.
im in until they either shutdown. Buyout or partership.
i don't care IF it takes, days, months or years.
I believe that Pela works. Just need to finalize the details of with which co- pilot.
Save the rant about shareprice. That is in no way an indication of efficacy, safety, applications of Pelareorep.
Yes it is an indication of shorting, manipulation, people trading on algorithms, or just plain old lack of confidence.
However, scratch bellow the surface.
When Roche started the Gobblet trials. First announced October 2020.
The announcement & discussions indicated.
" our colaborations & due diligence initiated with Roche, took many months to get to this point".
Read into that ..Roche is not goin* to risk their good name. Nore the good name of tecentriq without huge resurch first. Which they did.
So, while some yammer on about 20+ years. Four years ago Roche after much investigation decided the Gobblet trial was worth a look.
Things take time. Longer than many would like.
Moving closer to last few months.
Onc submitted a proposal to meet with FDA to discuss MBc phase 3 options. Agsin based on trial results ( Aware-1), thst took time.
Last time I checked the FDA is a government agency. Can't speak directly to USA gov agencies. However I know first hand, a simple tax modification request in Canada, took for me about 3 months.
onc can't say when the meeting will be, until they know. 
moving on...The pancreatic cancer results yeilded immediate support from PanCan, to move into the precision promis sponsored trial.
Regretably , the PanCan organization was underfunded & re- grouped with CGAR. 
Now, the pancreatic phase 3 trial will be conducted undef the guidance of CGAR.
In addition, a new arm has been added, as the result of an original $5million grant from PanCan.
All of these events, trials, grants, collaborations only hapoen after large DD on the parts of the various mentioned agencies & of course Roche.
BTW , the whole intent of Gobblet was to see if Pelareorep could increase the number of available people who could respond to tecentriq.
As/ the 2020 N.R. Only 1/5 patients would respond to tecentriq.
Even doubling that to 2/5 would create a huge additional market for Roche.
This is complicated & detailed stuff!
None of which has been negative. Hence the expected advancement to phase 3, with the pancreatic cancer. That being directed by CGAR.
The MBc is waiting FDA guidance.
Now...the all important big bucks?
oncolytics biotch can not fund a phase 3 in either MBc or pancreatic.
They need a business development change.
A buyout would be the quickest & perhaps most profitable for shareholders.
A licensing/ partership agreement would work. That as well would obviously elevate the shareprice.
Mutiple other $$ options are available.
Why has Roche not yet jumped in? Recall the existing arrangement to get to Gobbblet took months of discussions.
To get full value.....aka best shareholder value, 
id say, the FDA report, followed by first enrolment with the additional arm of Gobblet will move things along.
onc put out a N.R. Regarding the FDA meeting request, because it was deemed to be significant information.
Afterall the results of that could change negotiations considerably.
ill wait.....

[spesestsemper]

"onc can't say when the meeting will be, until they know. " 2024-05-09 | Oncolytics Biotech® Reports First Quarter 2024 Financial Results and Operational Highlights | TSX:ONC | Press Release (stockhouse.com) FDA Type C meeting granted to discuss plans for breast cancer. Oncolytics has been granted a meeting with the FDA to discuss the Company's planned registration

[Quentin30]

ONC can say when the meeting date is Canaduh... it's 75 days from the date of receipt of the submission... it's very clear for Type C meeting... The meeting may not even be in person, FDA may just send responses to ONC... that's quite normal too. If FDA disagrees with the questions asked, then it's more likely that ONC will meet with them on the "meeting date". Great

[Noteable]

Matt Coffey said the following "... We have submitted a request for a Type C meeting with the agency. We'll have that later in the month (May) and they have 35 days to give us their definitive (undiscernible) but I think this was a much more efficient way to get us to a BLA .." The entire FDA Type C meeting process takes at maximum 75 days from the sponsor's initial request

[Noteable]

The efficient way to get us to a BLA is through the biomarker CelTiLs work and the identification of surrogate endpoints (ORR/PFS) that ONCY accomplished and presented as recently as this last week's ASCO 2024 meeting. Title: Pelareorep driven blood TIL expansion in patients with pancreatic, breast and colon cancer. Presentation Type: Online abstract Abstract Number: e14625  

[Noteable]

As a result the efficient way to get us to a BLA is through an Accelerated Approval on previously mentioned biomarker/ surrogate endpoint results that have been demonstrated in ONCY's Phase 2 clinical trials.

[canadafan]

Actually the statement says " within 75 days". Back to my requested Canadian giv tax documents. I was told within 6-8 weeks. cant recall exact times. However was about 5 weeks. agencies give guidance based on statistical & historical practices. they could just as easy say....we have no idea. However, based on previous filings & previous turn around, they can say, within 75 days

[armedescapade]

Your post is so full of holes, it looks like a cat litter scooper. I'm back as promised. 

[Azzak34]

I asked around..... nobody cares. 

[ENEMENEMYNEMO]

Oh who is this now???  Maybe I'll come back too! Let us start with...When is the date losers?

[Noteable]

These are the nattering nancies of negativity who think that their irrationality is somehow funny.