Once NWBO announces either a plan for submitting to the RA's, or that they actually have submitted for approval, everything turns around. That will be the day that we finally see Sojo's "GUANLP" event. Price will immediately turn around and start heading to a realistic valuation.

I highly doubt that any of the partnerships will include much equity. I am convinced it will be a revenue sharing with a hefty upfront payment and maybe, but only maybe a small equity stake in the future. Hence, the SP will have very little meaning in terms of the partnership arrangement(s).

The filings have to be prefect and, sometimes, getting the last 1% right takes an inordinate amount of time...so it could even be June.

I believe Thermo was referencing the MIA when commented that approval was coming soon, and not marketing approvals. That said, I do think the approval process will move more quickly than some posters may think.

There are other initiatives that I think are interesting, but I'd like to see those develop further before I make them a material part of my assessment.

I don’t know why they would PR simply filing an initial set of documents not yet confirmed as filed.

I am a realist

it can logically be reasoned it will take several more months

Smith on Stocks article was meant to temper expectations. This isn't going anywhere anytime soon.

Um, I assume I don't have to provide a link to the SOS article that you yourself reference.

SOS certainly is a mouthpiece for the company,

Therefore, yes, management has started grooming investors via their social media/message board outlets that marketing apps will not be occurring as fast as investors believe.

And to be sure, I hope that you/your source is correct about April MAA. I'm certainly not saying you are lying.

His favorite excuse come early to mid May will be - “everything takes longer with NWBO!”

No shock here that management has started grooming investors via their social media/message board outlets that MAA will be taking longer than anyone expected or wants.

It is wild that NWBO just refuses to come out and say their plans.

if in fact this will take another two months.

Management has given no guidance on when it will file the MAA. As an out and out guess, I am estimating a filing by early June or possibly sooner. I have no meaningful information underlying this guess. It just stems from an appreciation of how complex the process is and how methodical NWBO has been in other document preparations.

I continue to believe they are waiting on ph 2 combo trial results to come out before applying to FDA

The uncertainty associated with cell and gene therapies can be managed through adopting novel approaches to pricing and reimbursement. The entry of Kymriah and Yescarta into the EU4 and UK markets highlights how real-world evidence (RWE) is becoming a powerful tool to demonstrate the value of cell and gene therapies in a clinical setting.

Conclusion
Cell and gene therapies launched in Europe to date have had varied pricing and reimbursement success. The clinical uncertainty resulting from limited data packages can make securing commercially viable outcomes for manufacturers a challenge. To support patient access to the important benefit these treatments can achieve, work should continue on implementing novel reimbursement approaches that recognise the unique value of cell and gene therapies. The experience of recent launches to the European landscape suggests that the potential for outcomes-based reimbursement and coverage with evidence development schemes as an opportunity to demonstrate the real-world value of these therapies should be explored further.

Alton was dumping imo. Not waiting LP.

Senti seems to believe there won’t be simultaneous approvals, but believes they’ll be timed in a fairly close stagger.

What percentage of the company received MIA

but did not receive MAA?

And that’s bad? Hopefully we’ll see some public good faith exhibited after MAA acceptance. The most recent SOW really seems to have duties set until MAA submission. So…

I found the most relevant statement from Merck to be that they are pursuing “derisked assets.”

Now that was interesting as the author does not seem to buy the idea that the FDA etc. demanded NWBO have a crossover because otherwise he would be pretty foolish to criticize the trial for including a crossover when there was no choice.

Looks like it. They want you out before NYAS. The only definite date on the calendar so far.