TDD, thx, your posts are informative as are several other longer term posters.
I have been away from this MB for some time but have kept abreast of events with the company and some of the discussions here. I had to set a new moniker, used to post as doingmybest, and, I am a long term shareholder who attended one of the company meetings in person.
I see the big picture here as the clinical process being the critical path and mfg has been developed as possible along the way. I think NWBO realized it was critical to wait the full 5 yrs post enrollment due to the positive backend trial performance, which cannot be calculated well by a K-M curve until actual events are recorded. Mfg has come along slowly but RA's do not require full capacity at approval time, though it is required to demonstrate startup capability as well as expansion plans to meet demand if demand exceeds startup capacity. This requirement becomes firmer with lifesaving drugs, particularly drugs that require repetitive dosing, such as a multi-dose regimen oncology drug, as patients cannot be left without treatment halfway through the treatment regimen. With DCVax the original mfg cycle covers the entire regimen, requiring sufficient cryo storage in place of additional mfg capacity. The next step is to ensure capacity growth as the drug becomes accepted as SOC by RA's and the respective medical community, which has not typically been an industry problem as growth generates profits to fund capacity expansion.
When NWBO stated they were hurdling many new scientific, technical and regulatory challenges they understated their mission, which really has been way too much for a startup like them to tackle. Fortunately for them there has been a long time horizon to tackle the challenges and the scale for GBM (only) is modest. Without the help of regulatory advancement over the last 5 yrs they would struggle much more. Global RA's lean more on established pharma's and have to hand hold startups much more as well as be much more cautious about startup company science and technical depth though politics also play a role.
On the one hand, the number of regulatory opportunities which have opened up to them is tremendous while envisioning the huge potential future of this platform is difficult. I've never experienced a long time horizon like this before but it does all fit together if they are able to capitalize on their regulatory opportunities, which have been well discussed here at length I believe by many well informed posters. On the other hand NVAX is a good example of how startup size companies are at a large disadvantage when they do not partner with a BP. NVAX is still attempting to tackle a global covid market with large scale plans when their larger competitors decided to start with a more focused plan. NVAX is now a year behind their competitors while probably possessing the best covid vaccine science. NWBO fortunately has a smaller first step to take, GBM, though they still need much more organizationally and I guess are planning to partner.
The future of the DCVax platform is very exciting for the world of oncology, but the pharma industry is open to all the same greed, politics and human vices as other industries are today. I am a proponent of startups partnering and NWBO is no exception, Merck would be a Godsend for them if they want to accomplish the big picture as rapidly as possible. Going it alone rarely works well. It takes a combination of resources and skills and it is not recommended in my opinion.
Some longtime posters here have a really good feel for the current status and what is likely to come, but I think we all should remember that even though the critical tasks have apparently been focused on, the work done to support this product/platform is truly absolutely minimal compared to what a BP would have done with this runway. There will most likely be slower approvals and platform development than hoped for, and, the best solution is for NWBO to partner asap. I think it is very doubtful they have submitted their BLA already, but, there very well could be some surprises here and they could have withheld communication on such an event if they are involved with new regulatory processes which they can state require confidentiality. I am hopeful there will be some breakthrough steps that will be accomplished utilizing some new RA pathways given the safe nature of DCVax.
One possibility here about the publication is that a better offer from the journal was accepted to provide more highlight to the article and they agreed to wait another month or two to take advantage, but I am an optimist about this. Q1 is looking good, hopefully this Q1.
GLTA
