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Haha you are deflecting and making strawman arguments.
You know for a fact that you have completely made up the claim that P2 is cancelled with. I RFI and now you’re trying to avoid responding to that argument because you know you have no response.
You really suck at this.
Changes nothing from what I said.
Look I'm all about optimism and hoping it gets approved soon.
But stop making up 'facts' and presenting it as hard evidence that this thing should get approved in March or April. It just sets everyone up for a letdown.
Take what the MHRA is giving you at face value and accept that the most likely timeframe is June/July.
If it's earlier, great; give reasons why it may be earlier, sure; but don't act like it should be earlier and use these absolutely non-substantiated 'facts' (such as Phase 2 isn't required if no RFI is pursued) to justify that.
“The thing speaks for itself” is a cop out. You may as well admit you can find nowhere that says what you claim. Which it clearly doesn’t.
Even if it did back up your claim which, again, it does not; the guidance you are quoting is for established medicines.
Flipper said:
Show me one place where it says Phase 2 is cancelled if there is no RFI.
Show me the link.
I can show you plenty of links and quotes that say definitively that the assessment is done in two phases.
You are the one claiming they don’t do phase 2 in some cases. Show me your evidence. Show me the link.
Jesus you are dense.
The onus is not on me to prove Phase 2 does happen. I am not the one that fabricated some bogus claim. The MHRA clearly says everywhere in their literature it is a two phase process.
You all are making up a claim that Phase 2 doesn’t happen if there isn’t an RFI. This is completely fabricated and nowhere is there any evidence that Phase 2 is cancelled if there isn’t an RFI.
My word sarcasm is completely lost on you people.
And you can reply to my posts, it’s okay. Don’t be scared.
They will not say anything about it in the 10K.
this board is glitchy as hell right now.
pay your hamsters better, iHub
Meh.
NVCR still down 80% YTD. NWBO 'only' down 23%.
Don't worry about NVCR.
Only worry about the next bit of NWBO news.
I still think it’ll go up, but we’re at the point where a 100% day will barely crack a buck (probably will take more than 100% to crack a buck by the time approval happens).
Tempering my expectations until NWBO can actually deliver multiple blows in a short timeframe. Sure hope approval breaks the dam but I’m not counting anything related to NWBO til the chickens hatch.
3 million volume on a freakin' line at $0.54. Looks like a pretty big buyer coming in at $0.54 today, and they have more ammo.
There you go with the insults again.
It really hurts, Kab. I expected better from you.
Cmon Ex.
If it’s approved, it’ll be in 2024.
The review is not going to take 365 days.
Even you have to admit that.
It’s not going to be in the asinine March/April timeframes people are putting out there, but a decision will happen in 2024.
This is called building a strawman, Kab.
Elaborate, but doesn’t fool anyone with even the slightest intelligence.
Best of luck on your next attempt, hypocrite.
Plot should be a bit more sigmoidal but yeh, that’s the gist.
Yep. The FDA is a fickle mistress and submitting a BLA without manufacturing is foolish. No problem at all waiting, Flaskworks as a method makes this all the more easily approved.
That being said, still wish the company would actually give guidance on this stuff. I have no idea why LP won’t just tell investors “Hey, we need to get manufacturing lined up, then we will be ready to submit to the FDA as well”. It baffles me that she thinks this all needs to be some big top secret operation.