Replies to post #788126 on NorthWest Biotherapeutics Inc (NWBO)

[Survivor2012]

My first read this morning--excellent narrative! Thanks biosectinvestor!!

[seekinganswers]

"They pursued a rational strategy — leveraging UK strengths in ATMP regulation and glioblastoma research to secure the first approval of murcidencel."

The phase 3 trial and MAA were DCVax. What is this mystery application you speak of?

[AllSheWrote]

Of course there are examples of companies applying to other regulators instead of the FDA, but the rest of this post is just absurd gaslighting. Yes, NWBO's decision to apply to MHRA first was strategic. It was strategic precisely because they knew they would not get FDA approval and I would wager my house that the FDA told them as much and probably told them to get approval somewhere else first, though we likely will never see the evidence of this because the company refuses to share information with shareholders. Of course, you know this, too, but you don't care because your job is to gaslight, make excuses, and spin doubt. For the rest of us, it is Common Sense 101. You told us for years that DCVax was the next standard of care and would sail through FDA approval because it was so important to get this revolutionary treatment to market. But that didn't happen. They never even applied to the FDA, and now you want to tell us this was all strategic, and going to the MHRA first "makes perfect sense" and is actually the better plan. Nothing this company does ever happens the way you people told us it would, but every time it doesn't you are standing by with excuses. The gaslighting is truly next-level. Everyone with common sense knows the FDA told them to go elsewhere first. Why? Because the trial results are scientifically invalid. This is the same gaslighting we heard from you over why they chose to change the endpoints of the trial. Everyone with common sense knows they changed the endpoints post-hoc because they learned in 2015 that the trial was headed for failure. You know this, too, but since the company refuses to share information with shareholders, it gives you free rein to gaslight, spin, and obfuscate. Utterly shameless. Enjoy the ride down.

[HyGro]

You just reinforced the point. ALL of these companies DID NOT file in the U.S. and are not approved in the U.S. and therefore missing considerable revenue.
FDA has a very high bar for stem cell therapies. No doubt they did review their data with the FDA -- their shareholders would HANG them if they didn't make a run at U.S. approval.

Look at Alofisel -- withdraw when the FDA requested additional data.

It is very common that biotechs apply in more than one country at a time. But if FDA says they don't have adequate data for FDA acceptance, they don't have another choice but to file in EU and other markets. You have just reinforced my point.

Kymriah was FIRST approved in the U.S. -- Kymriah received its first FDA approval in August 2017 for pediatric and young adult B-cell precursor acute lymphoblastic leukemia (ALL). FDA approval makes it easier in most other regulatory bodies as FDA has one of the most rigorous review processes.

[iclight]

Try showing an MHRA example. Are you that dense to not understand the EMA covers 27 countries compared to MHRA’s 4.

[AllSheWrote]

For years iHub clowns like biosectinvestor told us NWBO's FDA-sanctioned Phase 3 trial for DCVax-L would result in rapid approval as the FDA worked with the company to review its application and get this all-important treatment to market in record time. And then NWBO decided to not submit anything to the FDA. They submitted to the tiny MHRA instead. And now, biosectinvestor wants to tell us that submitting to the MHRA is a stroke of strategic genius and that it is, akshully, the better plan and tons of companies do it all the time! What? Who knew? When did MHRA become a better option than the FDA? Please explain as we'd all love to hear.

The companies that bioharm cites all applied to the EMA, not MHRA, and not a single one of them has FDA approval today. So his response is what one could only call . . . A LIE! Though he won't come right out and say it (because he knows how damaging it is), the "strategy" being hinted at here is that getting MHRA approval first will make it easier to get FDA approval next. Of course, the question then becomes, WHY? We were told for years by bioharm that this was a great trial with amazing results that show the undeniable efficacy of DCVax-L. So why, then, wouldn't they just submit this amazing data to the FDA first? The truth is, these clowns really don't want to dig too far into this topic because they know where the logic inevitably leads and just how damaging it is. For the rest of us who aren't spinning lies, excuses, and obfuscations, and who aren't trying to gaslight people for money, this is all Common Sense 101.