Oncolytics Biotech Inc ONCY

Type C Meeting Timings

[Quentin30]

Timings for Type C meetings are such that the request for the meeting must be sent 75 days prior to the meeting date.

So, we're looking at 24th June for the FDA's repsonse.. Presumably ONCY has disclosed its plan for its long awaited Phase III and wants the FDA 's blessing on several points.

If feedback is positive (and/or aligned with the answers ONCY was seeking), then ONCY and partner will start the process of preparing and submitting the Phase III clinical trial protocol.

The timings suggest to me that any Phase III might just start in Q4 2024, but more likely in 2025.

[jh1970]

Very optimistic view. Type B meeting in 2025 and maybe type A in 2026.

[Azzak34]

Why don't you read something before posting your nonsense!!! Type C is the exact one we want to be in.  Immediately necessary for an otherwise stalled drug development program to proceed. Type A meetings may include: Dispute resolution meetings as described in the Code of Federal Regulations (CFR), and in the Guidance for Industry Formal Dispute Resolution: Appeals Above the Division

[Quentin30]

Having to hold a Type C meeting means there are questions ONCY has that they wish addressing... Yes, it probably is related to potential biomarkers, and whether or not FDA will accept ONCY's suggested biomarker... the text of the new release still states potential, and not CONFIRMED... So, this Type C meeting isn't exactly the one we want to be in...as it would be quicker simply to get

[Azzak34]

Haha of course it says potential idiot, they haven't had the meeting yet.  ONCY know exactly what's going on with Bracelet, you think they'd schedule a meeting, in person or otherwise, If this was a stab in the dark?  Haha look at you clutching at straws. This is for Breast as well, the indication you said there was 100% likelihood never to happen!!!! What do you think the

[Noteable]

" ... this Type C meeting isn't exactly the one we want to be in...as it would be quicker simply to get on with the Phase III trial design, as per their SPA issued by FDA 6 years ago..."  No it isn't. Employing biomarkers and surrogate endpoints in Orphan/Rare diseases, like in metatstatic breast cancer, result in smaller registration studies and more particularly

[Noteable]

Employing biomarkers and surrogate endpoints in Orphan/Rare diseases, like in metatstatic breast cancer, result in smaller registration studies and more particularly opens the door for "Accelerated Approval" and smaller/quicker post approval confirmation studies. Haven't you jokers understood anything that was posted ad nauseum on this opportunity?

[Azzak34]

Exactly. This was to be my next reality check for Quenty.  He just doesn't understand what this means. If this is for Breast, imagine what's coming down the pike for Panc. 

[Noteable]

ONCY must be have some "compelling"  long-term surrogate endpoint and biomarker data from the Phase 2 Bracelet-1 metastatic breast cancer and AWARE-1 studies to request a FDA meeting. In June and December 2023 ONCY reported: Pelareorep-paclitaxel combination reduced risk of disease progression by 71% (hazard ratio of 0.29) compared to paclitaxel monotherapy 37.5% 

[Noteable]

Should read: " ...ONCY must have some "compelling"  long-term surrogate endpoint and biomarker data from the Phase 2 Bracelet-1 metastatic breast cancer and AWARE-1 studies to request a FDA meeting."

[Quentin30]

No, not MUST have at all Noteable, in fact many companies try and see what the FDA will accept... FAR better to get a nod before you design and or begin a trial, than to get a rejection afterwards... On the subject of trials... just how many successful Phase III trials has ONCY run now..? Besides the one almighty cluster-F^& a few years ago wasn't it..? And I recall the then CEO, Brad

[Buckhenry]

Great news today... interest is high... if only this translated to the stock price... but I know... please be patient..

[Azzak34]

No, don't be patient, you should definitely leave now. 

[Buckhenry]

I would love to leave but the rules state there must be an adult in the room so stockhouse has asked me to stay...

[Noteable]

Employing biomarkers and surrogate endpoints in Orphan/Rare diseases, like in metatstatic breast cancer, result in smaller registration studies and more particularly opens the door for "Accelerated Approval" and smaller/quicker post approval confirmation studies.  Consequently it would appear that ONCY has asked for a meeting with the FDA to have them confirm the biomarkers

[Quentin30]

From the AUGUST 2023 Earnings Call - Patrick Trucchio asked about Accelerated Approval for Panc. Patrick Trucchio Thanks. Good morning, and congrats on all the progress. I guess, just a couple of questions from me. The first is, can you talk a little bit about the pace of enrollment in the Precision Promise program and specifically, how much influence will you have on the conduct of this

[Noteable]

So Quentin30 believes in Jehovah  ... interesting !!

[Noteable]

Employing biomarkers and surrogate endpoints in Orphan/Rare diseases, like in metatstatic breast cancer, result in smaller registration studies and more particularly opens the door for "Accelerated Approval" and smaller/quicker post approval confirmation studies.  It has been already posted on this message board that the FDA is willing to consider innovative treatments in an

[Quentin30]

And that is your only response.. Isn't it time for you to post some details of some spurious trial with the vaguest of connections to ONCY.. I hear the local laundromat was bought by another outfit...  ONCY is surely next in their sights...

[Azzak34]

You alluded to being in the biotech industry yesterday, which I find inconceivable given your complete lack of understanding on anything to do with Biotech.  How is that you don't understand that in Biotech, as in other industries, there are changes in the landscape and adoption of new "ideas, drugs, processes" etc, every years? You don't know that RNA in oncology is being

[Noteable]

Perhaps ONCY's press release announcing their expanded treatment in pancreatic cancer is indicating what's in ONCY''s Type C meeting request, given ONCY's biomarker and surrogate endpoint results. Employing biomarkers and surrogate endpoints in Orphan/Rare diseases, like in metatstatic breast cancer, result in smaller registration studies and more particularly opens the

[Noteable]

This meeting and the timing of the pancreatic cancer press release is signaling ONCY's expanded intent in bringing pelareorep to market via an accelerated pathway.

[Quentin30]

And you KNOW about ONCY's intent... because...??  1) Your paymasters have told you what their INTENT is ? 2) You use such language to sound authoritative ? 3) ONCY's PPS has cratered 60+% in the 3-4 years since they have been paying your for your fluff pieces? Noteable - UNLESS you are an insider... YOu actually have no more clue about ONCY's intent, than anyone else on this bb.

[Quentin30]

NOT ONCE has ONCY mentioned "Accelerated Approval"... This is YOUR delusion... stop misleading investors...

[Azzak34]

Yaaaaaaaaaaaaay......he's back.  How's your portfolio been going lately Bahahahaha.  Get back in to Gamsetop bro, they'll get a bump eventually. 

[Azzak34]

They've also asked if you'll do better with spelling and punctuation. They asked me to pass it on. 

[Buckhenry]

Funny... they asked me go down to the lowest common denominator...and that is the forever blind pumpers here...

[Azzak34]

That is funny because you're the lowest common denominator. 

[Buckhenry]

For those thar can't see the bigger picture... unnoteable will post more worthless garbage in an effort to boost his ego.... even more... if that's possible..

[Peladawn]

Hey buck....grow up.

[canadafan]

A quick search shows without any doubt, the every single post buckhenry has ever posted has been an attack on another person or Onc as a company. Clearly his motive is ti distract from any positive news & try to destroy the credibility of this site. Positive news?He is beyond obvious.  The most recent being the upcoming meeting announced with FDA to define parameters for phase 3 trial

[jh1970]

Question : why they don`t give a names of partners and collaborators ?

[Azzak34]

Did you go read why your type B and type A comment earlier was really stupid?  What do you have to say for yourself? 

[jh1970]

After holding shares more then 25 years and loosing tenth of thousandth of dollars I have bad experience with ONC managment , which us a news and is doing something diffrent .

[Azzak34]

So you've held a biotech for 25 years and haven't picked up any understanding of how any of this works? I think that's a shame on you scenario!! 

[jh1970]

When did you buy your shares ? If you own any ?

[jh1970]

Yes, it is a shame. It is a shame that I believed  managment which keep me at dark and always is finding new excuse to change previous plan of delivering pela to the market. I belive in Pela that can make miracles and hope that some day in the future Pela will be on the market as a cure for all sick people , but I doubt that this managment will do it. Azzak34, I know I sound pesimistic and I

[Quentin30]

jumping the gun again Canaduh... 1) NO FDA meetings have been announced... ONCY has petitioned a meeting. The FDA may reject the request.. we don't know... and neither do you. 2) If you have seen the Type C Meeting Package then you know what is in it... this MAY be about the trial design, but won't be for the trial design... that will be submitted in the phase III protocol... It's

[Buckhenry]

You forever pumpers need to go stand in front of a mirror and point the finger at the problem. I would not have gotten down on your level if you had let folks have their view even though you don't agree. You drew first blood... so shut up and quit attacking those that have a different opinion. Otherwise I will have to double down. Your choice...

[Azzak34]

Bahahaha what an idiot.  I don't even know what twice the illiterate would like but I for one am begging you to "double down".  This board is for shareholders of the stock, or those that may be interested. Shorters, Fudsters and unscrupulous cowards frequent these boards to sow discontent and doubt. I wouldn't dream of going to another board to disparage their stock

[ENEMENEMYNEMO]

YOU CAN'T HANDLE THE TRUTH!

[Buckhenry]

It's the stupid ignorant folks like assak that make this site unpleasant. He is always assuming facts not in evidence... so maybe you more Senior pumpers should take him aside and try to educate him...

[ENEMENEMYNEMO]

BUCKY RULES!!!

[Buckhenry]

It's perfectly OK to speculate here... as long as you allow ALL to speculate. When you start ridiculing those you don't agree with you become just like the woke movement folks that burned Portland and Seattle down.  

[Azzak34]

Quentin30 - (4/11/2024 10:38:11 AM) RE:RE:RE:Type C Meeting Timings Having to hold a Type C meeting means there are questions ONCY has that they wish addressing... great insight, thathat's the whole point of the meeting stupid.   Yes, it probably is related to potential biomarkers, and whether or not FDA will accept ONCY's suggested biomarker... the text of the

[Quentin30]

BYON - bought at 15, sold at 32... I did just fine thanks..  delay in interest rate cuts will keep the pps depressed. CRSP - bought at 37 sold at 71... I did just fine thanks..  This is down predominantly on Verve news... as Kulkarni stated, when Boing has an issue its competitors rise in value... not so with Pharma... one company has an issue, the whole sector is tarred with the same

[Noteable]

Type C Meeting - Type C meeting is any meeting other than a Type A, Type B, Type B (EOP), Type D, or  INTERACT meeting regarding the development and review of a product, including meetings to facilitate early consultations on the use of a biomarker as a new surrogate endpoint that has never been previously used as the primary basis for product approval in the proposed context of use. https:

[ENEMENEMYNEMO]

Unfortunately you guys are the only ones that seem excited about this.  And who going to foot the bill???? Nothing wrong with dreaming but....

[Azzak34]

NeVeR GoInG To HaPpEN I sense a lil crack in the confidence there dummy! Can you confirm that you have zero shares, just so we can all laugh at you in the coming weeks. 

[Noteable]

" And who going to foot the bill? " The announcement will surprise you.

[Quentin30]

Well done, you found an FDA website.. You know the officers themselves use Google to search their guidances because their search facilities are so bad..!  another meaningless post from you... we're discussing the potential content of this pending Type C meeting, and you throw all the other types at us... Type C meeting is NOT just about surrogate endpoints... you could ask for FDA

[Noteable]

Type C Meeting - " Type C meeting is any meeting other than a Type A, Type B, Type B (EOP), Type D, or  INTERACT meeting regarding the development and review of a product, including meetings to facilitate early consultations on the use of a biomarker as a new surrogate endpoint that has never been previously used as the primary basis for product approval in the proposed context of use._

[Journeytc]

So there it appears to be Notable.  Type C meeting about "Early consultation on use of biomarker as surrogate end point.....".     AWARE study suggested PFS of individuals with biomarker at about 70% an awesome response rate, a paradigm shift in therapeutic.    For Bracelet, we must subtract 50% from the AWARE observed PFS of 70% to determine those who can

[Noteable]

Journeytc - thanks for your analysis. Actually the updated data from BRACELET-1 showed a median progression-free survival (mPFS) of 9.5 months in the paclitaxel plus pelareorep cohort vs. 6.3 months in the paclitaxel monotherapy cohort for a hazard ratio of 0.29 as of a March 3, 2023 cut-off date, was very good, which was supported by a 95% Confidence Index (CI) (95% CI: 6

[Noteable]

April 26, 2024 - Cancer biomarkers  https://www.patientpower.info/navigating-cancer/cancer-biomarkers

[Journeytc]

Great news....truly.    I think the FDA will accomodate a meeting within a month and a half.   I'm guessing this means ONC met key performance leaders?   No guidance yet on proposed target population and use of markers.    I'm guessing the Pela combo does better than ADC treatment in overall response rate and safety. As I recall they never reported

[Quentin30]

NO Journeytc, NOT in a month.. just because you think something... doesn't mean it is even vaguely a semblance of reality. Type C meetings take 75 days... from submission to meeting... what are you people smokin'?

[spesestsemper]

 here is a recent type c meeting timeline 2024-03-27 | CSE:RVV | Press Release | Revive Therapeutics Ltd. (stockhouse.com) 2024-04-23 | CSE:RVV | Press Release | Revive Therapeutics Ltd. (stockhouse.com) So they requested a type c meeting on march 27th and received the acceptance of the meeting on April 23rd . Meeting date june 9th

[spesestsemper]

See above post on how oncolytics biotech should have handled the fda meeting announcement . Its quite frankly bad form not to let the shareholders know the date of the meeting . 

[Peladawn]

Oooooooooooooooh......Bad form.......I's selling.... that's it for me!

[Peladawn]

Hmmmm....even though there's still no proof Trump is guilty of any crime whatsoever, the highly left-wing media still tries to accuse him of whatever they can get away with.

[ENEMENEMYNEMO]

Very true.  Never seen a biotech not immediately post a NR when the FDA grants a meeting and the date of said meeting.  No fault of Matt here though because they don't have a date yet as their request has not been formally accepted. He just had this 1st Q Financials all done up, cocky pr-ic-k  and didn't want to change it in expectation of a date.  He ain't got it

[ENEMENEMYNEMO]

One of you suck holes must surely have a contact in the company.  Let's here a date!!!

[Peladawn]

Hey En.....just fyi.......hear is spelt "hear", not here

[ENEMENEMYNEMO]

That the best you got??? You meant "spelled" I think...unless you want to bake some bread or you are a stuffy Englishman? Which is it?

[Noteable]

At the 2024 RBC Capital Markets Global Healthcare Conference Fireside Chat on May 15, 2024, Matt Coffey stated that the FDA Type C meeting with a focus on ONCY's planned registration-enabling trial for pelareorep in breast cancer was scheduled for approximately 35 days after the date of request. So we should expect to be hearing more about the outcome of this Type C meeting sometime next week.

[Noteable]

Bio 2024 -  June 3-6, 2024 San Diego Convention Center, California  https://convention.bio.org/about-bio Theme: Are you prepared for the oncology paradigm shift? The emergence of powerful precision and personalized medicine platforms is ushering in a renaissance in oncology drug development. https://convention.bio.org/sessions/oncology-endgame-assemble-shine

[itntdf]

would be happy if it is that quick.  however, the fda timelines for type c meeting is as follows: oncy made request on/around april 11.  fda "required" to respond within 21 days of request for meeting.  actual meeting to take place within 75 days of oncy's request. a date for the mtg seems to be between the 3rd and 4th week of june based on the following: request on

[Noteable]

Listen to the RBC Capital Markets Global Healthcare Conference Fireside Chat .... Matt Coffey stated that the FDA Type C meeting with a focus on ONCY's planned registration-enabling trial for pelareorep in breast cancer was scheduled for approximately 35 days after the date of request.

[itntdf]

at about the 24:20 mark, matt said we have submitted a type c request for a meeting, and we will have that later in the month and then the fda will have 35 days to (and i could not understand what matt said at that point). replayed it a number of time but i just could not make out what he said. no mention was made that i heard regarding oncy's submission of a meeting package which is due at

[Noteable]

35 days from receiving ONCY's request.

[Noteable]

At timestamp 24:20 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 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 .." So as it stands the Type C meeting will happen before ASCO 2024, which is

[Noteable]

JohnnyYEG has come to the logical conclusion of this overall discussion... "And how many biotechs, themselves without buyout or partnership, ever see a phase 3? Rarely... they are most often bought out ! ..."

[itntdf]

yes, this seems to support the notion that oncy has submitted its package: Ongoing discussions with our clinical collaborators and partners have helped us to prepare a robust, compelling briefing document,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. “We eagerly anticipate our discussion with the FDA to align on the design and objectives of the registrational trial

[Noteable]

ONCY has earlier stated that they submitted a "compelling" brief, that happens to be documentation that suffficiently supports the purpose of the requested meeting, which in ONCY's case is to guide a discussion with the FDA to align on the design and objectives of the registrational trial for pelareorep in breast cancer. One could surmise that based on what ONCY has stated, the

[Noteable]

Some of the compelling data that like is in ONCY's brief to the FDA likel includes clinical outcomes that supports the following reported findings: Pelareorep-paclitaxel combination reduced risk of disease progression by 71% (hazard ratio of 0.29) compared to paclitaxel monotherapy   37.5% confirmed overall response rate with pelareorep-paclitaxel vs. 13.3% with paclitaxel

[Noteable]

Stockhouse Logo Search Companies, etc     Quote | Bullboard | News | Opinion | Profile | Peers | Filings | Financials | Options | Price History | Ratios | Ownership | Insiders | Valuation Oncolytics Biotech Inc T.ONC Alternate Symbol(s): ONCY Healthcare Biotechnology Oncolytics Biotech Inc. is a biotechnology company. The Company is focused on developing pelareorep, an

[ENEMENEMYNEMO]

EXACTLY...NO DATE! Having a meeting time is big news for a pissant company like this. It'd  be a headliner if they had it!

[Noteable]

...... We have submitted a request for a Type C meeting with the agency. We'll have that later in the month ...

[Noteable]

Type C FDA meetings are a "catch-all" category and include any meeting concerning the development and review of a product that does not fall within the scope of Types A or B. The FDA notes that it will attempt to schedule all Type C meetings within 75 days of receiving the written meeting request.   When requesting a Type C meeting, Sponsors can request a written response to

[Noteable]

Type C meetings are reserved for issues that do not fit in the Type A or B categories and can be used to consult on the use of a biomarker as a new surrogate endpoint that has never before been used.

[Noteable]

Type C meetings that set up the use of a biomarker as a new surrogate endpoint also set the stage for an Accelerted Approval request.

[Noteable]

From the FDA directive on " Considerations for Discussion of a New Surrogate Endpoint(s) at a Type C PDUFA Meeting Request" "FDA and industry believe that early consultation between review teams and sponsors is important for development programs where the sponsor intends to use a biomarker as a new surrogate endpoint that has never been previously used as the primary basis for

[Noteable]

Re: Considerations for Discussion of a New Surrogate Endpoint(s) at a Type C PDUFA Meeting Request" - Prescription Drug User Fee Act (PDUFA) was enacted in 1992 - Leading up to PDUFA reauthorization, FDA and stakeholders negotiate goals - PDUFA outlines the “user fees” drug sponsors must pay for FDA activities related to prescription drug reviews - FDA agrees to user fee “goals”

[Noteable]

And my experience has shown me that the FDA has clearly outlined their path towards granting an accelerated approval when a study that compares the investigational drug to an available therapy (or placebo, if there is no available therapy) in clinical testing or from a study that compares the new treatment plus SOC to the SOC alone and clinical evidence indicating a substantial improvement

[Quentin30]

You state this again and again, and yet ONCY management has NEVER mentioned Accelerated Approval to shareholders...  do you know better than them ? Anyway, here's hoping that by the end of June, ONCY management can articulate to shareholders exactly what their Phase III will look like. Until then, everything else is noise... and in the meantime, the pps is still dropping, now down 25

[Noteable]

Perhaps I do.

[Noteable]

And the path towards obtaining an Accelerated Approval has been clearly prescribed by the FDA, and one that appears ONCY is taking, particularly given Matt Coffey's recent comments on acquiring an expedited BLA.

[Noteable]

Or as Matt Cofey said .. (quote) " an accelerated BLA ".

[Quentin30]

accelerated BLA is not accelerated approval... there are many routes to have a BLA approved in less time than is the normal goal date... Fast Track, Breakthrough designation, Priority Review and Accelerated Approval. Accelerated Approval is VERY different... approval is granted on a yearly basis, it is conditional, and is determined via a Phase IV trial... Matt has confirmed that Phase III will

[Buckhenry]

It's very clear that pumpers here are desperate and grasping at straws.  This reminds me of watching the goofballs on cnbc  speculate on the first fed cut... they have no clue yet they talk like they have direct contact with the fed chairman..

[Azzak34]

Orange man gonna be wearing orange overalls soon! 

[m00nsh0ts]

More likely, the judge will be behind bars under 18USc241 for violating Mr. Trump's constitutional rights. 

[Peladawn]

Moonshots..... couldn't agree more...that whole NY so-called "trial" was a complete farce and an absolute embarrassment to the US justice system in the eyes of the whole World....

[fasttrack5]

Talking about brainwashed. HELLO

[Peladawn]

See what I mean...there's another perfect example ....fastrack can't see the forest for the trees!...

[CMHarring218431]

All I know is that Europe has had enough. Same topics of major concern here are affecting the political landscape abroad. Across the pond, the liberals and socialists are and will get pounded by the angry population. Did any of you liberal types happen to see that most Americans  would like illegal immigrants deported? Sanity is on the way back

[Angler101]

Yeah CM, and I wonder how many Libs know that the Trump campaign has raised over 400 million dollars since the New York fake trial,  a substantial amount of that from blue states, 12M alone from Nancy's feeding trough in California....how would they know,?....because one certainly would never hear something like that on CNN, MSNBC, CBS, etc....would they?

[Buckhenry]

This post has been removed in accordance with Community Policy

[Peladawn]

This post has been removed in accordance with Community Policy

[Azzak34]

Haha that turned quickly. Why react when I'm clearly having a pop at the Buckster? This isn't really the forum to discuss policital beliefs anyway, there's Reddit for that.  You'll have your election, cast your votes and see what happens. Do your college best to live your life and not get so bogged down in things beyond your control. 

[Peladawn]

Sure....after all, what could be less important than the the future of democracy, right Azzak?

[Azzak34]

Neither will have an impact on it, stop working yourself up.  Doesn't matter who you are, you break the law you deal with the consequences. Everyone held to a single standard!!! 

[Peladawn]

Sure.....whatever you think....

[Noteable]

"accelerated BLA is not accelerated approval" ... up until the time that the FDA grants an Accelerated Approval .. which in turn results in an Accelerated BLA, with full approval conditional on a confirmatory trial.

[Noteable]

Bracelet-1 demonstrated that pelareorep is effective as a monotherapy when coupled with paclitaxel veresus the control arm of paclitaxel alone. If you Quentin30 were in industry and had any relevant industry experience, which doesn't appear to be the case,you would know how this is relevant to pelareorep when combined with other immuntrherapeutics and small molecules agents. Bracelet-1

[Noteable]

And because I have to keep repeating myself  an Accelerated Approval/Subpart H – Unlike Fast Track, Priority Review, Breakthrough, and RMAT which reduce FDA’s review time, Accelerated Approval shortens the Sponsor’s clinical development time – For serious conditions with a meaningful advantage over available therapy – Permits the use of a “surrogate endpoint” that is likely to

[Noteable]

FDA's "Guidance for Industry - Expedited Programs for Serious Conditions – Drugs and Biologics" https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics.pdf

[Noteable]

Its also obvious that Quentin30 doesn't understand very well since Fast Track, Priority Review, and Breakthrough Status serve to reduce the FDA’s review time for approval In contrast, Accelerated Approval shortens the Sponsor’s clinical development time by granting a conditional approval while the Sponsor conducts a confirmatory trial while the drug is being marketed and earning revenue.

[Quentin30]

well done, you can copy and paste like a trooper can't you Noteable.!! A sponsor will always request a Face to Face meeting... FDA decides whether this is necessary or not... it's quite pointless for a sponsor not to request a F2F meeting, because the repsonses can always be not what the company was expecting. what was the point of your post...??? with skills like this are you sure you

[Azzak34]

I can answer this one!! He quoted exactly what a Type C meeting is for and what that means.  Have a pop at gaining knowledge and posting facts, rather than the speculation you accuse others of.  How are your stocks doing Quenty? Been awful quiet lately!! 

[Quentin30]

Stocks are doing fine thanks Azzak... quiet ?  there's not really much to post about... we're waiting on news from ONCY on how they will pay for x2 Phase IIIs, and whether either will go ahead. Yes he quoted it... but in practical terms, applicants rarely ask for written responses... that's my industry experience on the matter... more valuable than a copy paste.. You can learn

[Noteable]

At 24:20 timestamp of the May 08, 2024 RBC Capital Markets Global Healthcare Conference Fireside Chat, 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

[Noteable]

Correction : .. May 15, 2024 Fireside Chat.

[Noteable]

The FDA Type C meeting to discuss ONCY's novel biomarkers and surrogate endpoints for breat, pancreatic, anal, and colorectal cancers should open the door to ONCY's request for an Accelerated Approval for pancreatic cancer as a disease with an orphan and rare disease with an unmet treatment need. The reason for this is that ONCY had run several Phase 2 clinical trials for this cancer and