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Hoping it's not a "spur of the moment" like it has been in the past.
Wondering if some are hoping/expecting an approval announcement next week. Far to early IMO, but you never know these days.
Christ is King
Question Doc,
In a hypothetical situation, let's say that the inspections from the MHRA are delayed and it'll take the first half of 2024 to complete (basing on the statement from the 10k). Is there a possibility that NWBO was skipped in the March CHM meeting, and can be in the next CHM meeting instead?
Sorry, perhaps I should ask again:
I know, I was being a bit sarcastic.
But their vernacular and speaking methods are very similar, along with their "predictions" and "know-how".
His new name is Smitty /s
Sept 2023 the price dipped to $0.43. Within 30 days after the price rose above $1.00
I do not believe the recent price drop is indicative of "negative winds". More than likely it's manipulation.
Apparently, you can't post twitter (X) links from members who have been banned from iHub.
My goodness Newman you need to think this critically. You are constantly pumping and leading others astray.
Validation does not occur immediately upon submission. It takes several days, if not over a week for the MHRA to validate a submission before assessment.
NWBO submitted its MAA right in the middle of the holiday week. Christmas Eve, Day & New Years occurred literally within two weeks after it's submission. It is not probable, but highly LIKLEY that the MAA wasn't validated until the first week or two of January.
We also have no idea if NWBO will inform us if they received an RFI either.
Stick. With. The. PR.
Newman, you are setting yourself up for major disappointment. NWBO THEMSELVES stated that they filed for a 150 day turnaround, with an expected RFI. Looking for approval news this month is extremely unlikely.
You are going to bring people into a false sense of hope. Stick with what the PR stated.
Everyone,
The closer we get to approval, the more pressure we are going to see on the PPS. They will try and drive this thing down as far as they can. It's going to take some resolve to endure.
Not sure if approval will come 2nd or 3rd quarter, but in my very honest opinion, we will get it.
For now, ignore the noise and keep your eye on the prize.
Makes sense, thanks.
IMO, MHRA running behind will be the main factor of a late approval.
Chart looks like a damn Richter Scale today
I think some here are putting too much faith on the CHMP meeting next week.
You are going to disappoint yourselves again. Just rely on what the previous PR stated: 150 Day turnaround request with possible RFI.
LUCKY BREAK Man given just nine months to live stuns doctors as world-first treatment ‘eradicates cancer’
https://www.thesun.co.uk/health/26487860/glioblastoma-brain-tumour-cancer-immunotherapy-treatment/
Newman, the company themselves stated that they expect an RFI. If that is the case, more than likely so approval will come after May.
There is no guarantee that the CHM meeting will provide good news. Best to go with the 150 day (+60 day RFI) review period that the company expects themselves.
Clearly LC is baiting for engagement. LC knows the guy is a lunatic but taking advantage to sow discourse.
Oncovir was my first guess as well.
I agree with FeMike. The 10k is likely to just hash out what occurred within the last few months. If something substantial were to be included, I would think it would have been PR'd. Maybe we'll get a nugget or two of information that we'll have to theorize over.
I expect it to just be a summary of recent events and nothing more. Again though, more than happy to be wrong.
BioVie Shares Double After Positive Data for Parkinson's Disease Treatment
BioVie shares doubled to $2.89 in premarket trading Friday after the company said its Phase 2A study of NE3107 suggested improvements in non-motor symptoms in patients with Parkinson's disease.
The company said these findings complement previously reported improvement in motor symptoms in patients treated with NE3107 and demonstrate potential intrinsic, levodopa-enhancing activity of NE3107 that is consistent with data from animal models.
NE3107-treated patients experienced a significant improvement for the sleep/fatigue domain of the Non-Motor Symptom Scale in Parkinson's disease, whereas placebo patients experienced a worsening.
Sleep/fatigue domain improvements correlated with motor score improvements. More patients on NE3107 had improvements in the NMSS sleep/fatigue domain, while more patients on placebo worsened.
https://www.google.com/amp/s/www.marketwatch.com/amp/story/biovie-shares-double-after-positive-data-for-parkinson-s-disease-treatment-6fca8fee
We are setting ourselves up for disappointment if we believe approval is in a few weeks.
Better to assume a full 150 day approval process.
Thus far, this is what I found:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173751438
While I also believe an RFI will not be required, NWBO themselves stated that it was anticipated. Of course, they could have been covering all bases; Under-Promise and Over-Deliver:
Wasn't there an email, or a post on here within the last few weeks that stated the 80-day Phase 1 period started once validation was complete?
It'll be a lot easier to email the MHRA and see what they say about Phase II being a requirement absent an RFI.
Does the March 9th date take into account the validation period?
If we assume 14 days to validate (especially due to submitting during the holiday season), that will mean Phase I started Jan 3rd.
80 days from Jan 3rd is March 23rd. Right around the same time of the CHM meeting.
Ah, thanks.
Stonk, apologies. I was referring to another post about the NICE status update. Replied to your previous post on accident.
A previous poster stated that it was updated to “in progress”.
If there has been an update to it’s status, wouldn’t that mean the MAA application is well into review and validated? Doesn’t NICE attempt to coordinate its review along side applications?
I have no doubt that NWBO is waiting on MHRA approval before submitting to the FDA. Not only will UK approval confirm the robustness of our application, but it will also apply pressure to the FDA
Furthermore, we will need increase manufacturing capacity to support both the EU and UK regions. Perhaps NWBO will wait until Flaskworks is approved as well to ease any concerns the FDA may have about capacity.
iHub had a website message saying that they were working on it.
MHRA Newsletter February 2024
https://content.govdelivery.com/accounts/UKMHRA/bulletins/38d441d
Regardless, $3 buyout for a brain cancer vaccine?
Absolutely not.
Hopefully our submission will complete phase 1 by the time the CHM meeting rolls around.