Cannot get any better price to start a position and to add to your existing position as the "game" is in such late (delayed, delayed and delayed) phase. It could be any day now for the news we have all been waiting for.
Generally speaking the market (the Wall Street) is being preparing a trap for retail investors with the support of the most corrupted institution FED. Inflation is real, rampant and fierce, American printing machines have to be stopped at some point in the near future. In the case of nwbo, it is generally detached from the general market as it is a development stage biotech company about to reveal its pivotal trial results
Large swaths of time are difficult to internalize.
In late 2014, LP said they were talking a lot about the prospects of possibly needing to meet massive demand.
In 2015, they began “spring refreshers.” These were blinded reviews and systematic tabulation of data.
In June 2015, the NIH started funding a FOUR YEAR grant project for Shashi Murthy (and his team) to develop a closed system automated dendritic cell generator, and later, Murthy and Flaskworks would develop a completely enclosed end to end manufacturing system for products just like DCVax.
By July 30 2015, the DCVax-l trial’s screening process was temporarily halted.
Between July 2015 and 2020, imaging specialists worked very hard to improve their ability to differentiate progression from pseudo progression.
By September 2015, Cognate set out on a three year mission to expand production capacity for biologicals like DCVax-l and other products, and, as we later found out, according to LP, had planned all that time to ultimately complete a management buyout.
Over the next few years, NWBO’s “spring refreshers” kept proceeding. More blinded review and data tabulation.
By 2018, Cognate implemented its management buyout from Toucan. It still maintained its future manufacturing agreement with NWBO.
By 2019, Cognate (Memphis) had achieved GMP Certification in Europe.
By August 2020, Shashi Murthy and team obtained its dendritic cell generating patent for automated closed system manufacturing.
By the end of August 2020, NWBO acquired Flaskworks and all of Shashi Murthy’s and North Eastern University’s applicable intellectual property dealing with cell manufacturing.
By September 2020, the DCVax-l trial endpoints had been changed and/or reorganized to prioritize external controls. It maintained its original primary endpoints as secondary. The new endpoints potentially allow consideration of rGBM in addition to nGBM.
By October 5, 2020, NWBO locked the trial, in my mind partly because they would now/soon be more prepared to deal with imminent increasing demand. Something they were not prepared to handle in late 2014.
By Autumn 2021, NICE developed a temporary rule allowing drug approval before their price evaluation. It is up to the companies and NICE to work out interim cost neutral payment. Cost neutral includes accounting for projected benefit. Cost neutral does not mean no profit.
By October 1, 2021, the Lancet article dealing with the appropriateness of external control arms in some cases was written. Regulators contributed to this article.
By October 28, 2021, Advent in Sawston received HTA certification.
By November 19, 2021, the World Health organization finally published the new definition for GBM. This definition serendipitously is harmonious with DCVax’s method of action against GBM, while at the same time, the new definition essentially eliminated most competition.
By now, FDA draft guidances and ultimately relevant guidances have been developed by the FDA that are serendipitously mutualistic with DCVax’s method of action.
Sometime this month or early next month, Advent in Sawston will, IMO, receive gmp certification to make DCVax-l (at an initial pace of 45 batches per month.)
Sometime in the coming days/weeks, imo, a journal article will announce topline results for the DCVa-l trial and explain those results in depth.
Sometime in the coming weeks/months, DCVax-l will be approved for GBM
Sometime in the coming months, imo, closed system automation will start to produce DCVax-l batches at a higher rate per month and lower cost.
Following that, NICE will likely provide their own price reimbursement evaluation.