Harry1969: "Not sure how anyone can think that this is anywhere near 100% de-risked."
Some rather informed investors consider the following when assessing the current and future risk to the share price of NWBO:
1) The DCVax-L SAP endpoint changes logged with the regulatory authorities of both the UK and Germany confirm their acceptance to the amended PIII SAP. The primary endpoint is mOS.
2) As documented several times by ATLinsider (on this MB as well as on Twitter) the company indicated that they would only perform datalock once the main regulatory authorities have no dispute with the SAME endpoint changes. Since datalock has occurred, there is high confidence that there is no dispute with the amended SAP (would include FDA).
3) ATLinsider has compared DCVax-L treatment mOS (from the last presentation with gave the statistics) with other GBM treatment studies (as stated in the amended SAP) and has shown that the DCVax treatment mOS will be significantly longer than the other studies. Look up ATLinsider's table here or on Twitter to see the comparisons.
4) DCVax-L safety has been previously reported to be equivalent to the placebo group. Since the treatment compounds (dendritic cells) come from the actual patient AND there has been no halting of any of the trial phases over 14 years due to safety, this risk is virtually nil.
Outcome Scenarios:
a) The Unreasonable Worst Case: If you agree with AF his ilk, then basically he portents the company is a fraud and has known this trail failed years ago. LP put her own money in this company to perpetuate the fraud for some incomprehensible reason. Thus, TLD will never be released and the company will dissolve and go away. If one would even attempt to listen to Dr. LL, one would completely reject this scenario.
b) A Reasonable Worst Case: After pondering ATLinsider's mOS data, assume that DCVax-L is statistically significant on the primary objective (mOS) only AND the FDA is not on board with SAP: In this case it is very likely both the UK and Germany would approve or at worst case allow the equivalent of an "emergency use authorization" for DCVax-L treatment of GBM. Marzan (from this MB) has estimated revenues for UK and Germany only with a modest sales multiple, and comes up with a value of $8/share. My computation is slightly lower at $7/share. Note: the Sawston facility is near completion and they are hiring employees to run the business and facility (search this message board for the posted jobs).
c) Other scenarios that include FDA approval and BP buyouts: These scenarios are left for the reader to complete as I am only addressing the "de-risked" side of the situation.
The largest risk to the share price would be another round of dilution to raise cash to continue the business. This has also been adjudicated on this MB many times, and it is likely there is enough cash to keep them going for several more months before another cash infusion would be needed.
I am not going to engage in debate of the above points. I offer a summary of these to help you understand why several active posters on this MB believe there is not much risk left to the share price.
Peace.
AI
