LL is a USA physician, and thus cannot prescribe a drug in UK, Canada, or EU.
She presented the statical at Utah with external validation of positive and negative trials. She then went on in May and Mt.Sinai to presnt the model and SAP analysis overview with many forward looking statements about how to think about combing agents with DCVax with a couple case studies. In late summer, she told colleagues to save tissue at patient expense cryogenically frozen rather than paraffin as paraffin will make tissue unsable. Can pretty much guarantee the paper was submitted before this. So LL has seen data and continues to speak positively with expectations to have drug in the hands of other soon. PERIOD
UK and EMEA have approved these endpoints and production capability is ramping up. The 10Q alluded to Franhouffer still being in the mix and we all see Advent nearly done building out an workforce and should receive certification correcting after minor issues loke hiring a fre more people. This tells you 30-40% world revenue will soon be approve.
Flashworks per DI is preparing to do comparability studies with Flashworks which should be all that is necessary to get that to the finish line. This is not an efficacy comparison. My guess is they will need to show similar cytokine profiles on testing and safety of one or two doses in volunteers, probaly in the neighborhood of 20-30 GBM patients. Enrollment by AK et al in UK will be fast. That will not take long at all. That too is “coming soon”. UK/EU is in the bag and it certainly seems that submission there has begun due to the Swaton process for CGMP manufacturing approval.
This all creates revenue in 2022. So how then are we dropping like this. Serious money coming soon there.
On top of that, CRL is already approved for production in US & Canada. Ther is some questions of contracts here, but they too were alluded to as a manufacturer in a recent 10Q. After MT. SINAI, it was clear that the US application could be completed soon. People assume no news means they have not submitted the final data package. I think this is absolutely crazy and that the publication is a smokescreen for this, but absolutely real and on track to be ‘coming soon.’ This is all doubted based on CT.gov not getting updated, really? What of they drop that shoe before Cert and everything else?
Meanwhile they take out a full page add at ABTA which meets the limits of possible coming soon campaigns and remove their exhibit booths that would cross that line if not altered.
Your choice here is that everything is moving forward positively with regulators or that LL and UCLA are implicated in a criminal conspiracy case. Cases can be lost but this is what LL and LP would be conspiring to do along with others. The later is cuckoo bananas, bat $hit crazy.
This ‘bear raid’ is seen in many small biotech as big news is pending. I may have clarity on releasing my powder again soon and I love these prices.
That is how I see the present and near future worl which amounts to Orbis or Orbis like approval in the next several weeks.
FDA rushed to get SPINRAZA on Dec 23 to be ahead of Christmas holiday. That drug is different in many ways, like being a pediatric drug for an orphan disease, that is fatal and in some within months or others who melt away in fromt of their parents over years. They rushed to get er done in about four months.
Just what would they do here? Is what I call a coming soon campiagn happening bc that timeline project Jan-Feb approval in US.
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