@Barkbuddy2 Is this not why $NWBO chose the MHRA first? If you’re insinuating it’s taking sooo long because the MAA has been corrupted by big pharma, we could have just pulled the bandaid off quickly then and applied to the FDA at the same time as the MAA and had an FDA decision in 2024.
Officially at 900 days, on a 150 day MAA assessment, with no backlogs. 😳 This is pure and absolute insanity. Everyday I wake up thinking, “today has to be the day.”
How long will $NWBO let this drag out before they finally break silence and offer an update of some sort??
@aVoice4ALS@FDACBER@US_FDA The unfortunate part here is, @iamalsorg doesn’t appear to be behind #NurOwn the way the need to be. They’ve had many important meetings lately with important ppl and audiences, but they seem to be pushing Clene instead. We need @iamalsorg to be pushing for NurOwn as well. $BCLI
Maybe I’m old-fashioned, but if $24,000,000,000.00 gets spent and the problem still looks worse than ever, I think the people in charge should have to explain themselves.
Gavin Newsom is a fraud.
@aVoice4ALS In BCLI’s Feb 26 PR, Chaim stated they were engaging “in high level discussions” RE: the CP/AA. Yet, Makary ignored the CP? Nick stated he would not rest until the CP was addressed. It’s been 10.5 mos. When will Nick update the community? What’s the plan of action?
@LisainNJUSA@DiegoPlatzer@AlexZarac 😂🤣 @DiegoPlatzer maybe you need to learn how to read, write, and spell, first. You wrote a whole paragraph of nonsense, that no one can understand. 🤣😂 So many potty mouths in this thread that think that using profanity makes them big, bad and scary. Truly sad.
$NWBO October 6th will make 6 yrs since the P3 trial was data locked (2020). The average biotech takes 6-10 yrs from a P1 trial, through FDA approval. For us, it’s been nearly 6 yrs just since the P3 trial ended, and we still don’t have a single approval. Absolutely mind-boggling
@LisainNJUSA@AlexZarac Let’s talk actual facts: 13k Pts die a yr in the US of GBM. You quote a few ppl that are long-term survivors. Great! Had $NWBO applied to the FDA in 12/23, instead of MHRA, they’d have had a PDUFA in 2024, giving more, than just a select lucky few access the last 2 years. FACTS!!
We’re sadly nearing 6 yrs since P3 trial data lock, without a single regulatory body approval, despite paying millions to consultants to assist with regulatory licensing. Should $NWBO management be replaced with more competent, knowledgeable, and regulatory aggressive leadership?
The laws in Los Angeles, California make no sense
The truck on this street must pay an hourly fee to park here by the sidewalk
Right next to the truck is a homeless person that can block the entire sidewalk and live there forever for free
You can’t make this make sense
@aVoice4ALS When is Nick going to provide a formal update and a plan, given the fact the FDA ignored the CP. Will there be a suit filed in a court of law? He previously said he will not rest until we’re heard.
@aVoice4ALS In BCLI’s Feb 26 PR, Chaim stated they were engaging “in high level discussions” RE: the CP/AA. Yet, Makary ignored the CP? Nick stated he would not rest until the CP was addressed. It’s been 10.5 mos. When will Nick update the community? What’s the plan of action?
@Nina_kd@Anonymous275111 Holy heck @Nina_kd, how many shares do you own now? I think you’ve reported adding like a million times—good for you, as long as this gets approved.
@RichFairgrieve Ha! I’m not the CEO of a $345M biotech who’s had 20 yrs to plot the course. I’m also not the 1 who spent millions on consultants to assist with the regulatory process. And you’re satisfied with where we are? I prefer progress, communication & accountability. Apparently you don’t.
$NWBO had YEARS to select their first regulatory body. The P3 data ain’t changing. They clearly chose wrong. Absent an Orbis-type approval, this MHRA decision 1st, was an epic fail for management. A BLA to the FDA in 12/2023, would have resulted in a PDUFA date/decision in 2024.
S&P ⬆️ 0.61% and $NWBO ⬇️ 10.45%. Great job—your continued silence and lack of MAA updates are really helping your company, the share price, as well as retail investors, whom are your only source of support, given 0 institutional interest. Can you really drag this out any longer?
🚨 Stephen Miller says the scale of welfare fraud is SO MASSIVE that eliminating it alone could balance the ENTIRE federal budget
"The amount that has been fleeced from us is in the HUNDREDS OF BILLIONS of dollars."
"We could balance the federal budget if the only dollars that went out of the treasury went to individuals who were properly, lawfully, correctly eligible to receive them."
This should infuriate EVERY taxpayer.
@SnackBioTech You sir still haven’t committed one way or another as to whether $NWBO gets MHRA approval or not. I’ve asked for your opinion several times, but you won’t commit or answer. Why?
@groovygrahams Tell that to the families who’ve lost loved ones in the last 2 yrs. The facts are the facts. The data is the data. Upon an accepted BLA by the FDA in Dec 2023, we’d have had a PDUFA date in 2024. Those are facts. Here we sit, mid-2026, twiddling our thumbs, wondering! Ridiculous.