Saturday, July 20, 2024 11:44:19 AM
Re: None
Saturday, July 20, 2024 11:34:16 AM
Post#
707229
of 707235
NCI researchers along with Dr. Liau and her colleagues did genetic profiling analysis on tissue samples from the p3 trial. In February the same group of NCI researchers just published a paper on long-term GBM survivors. The interesting part is that in the paper published in February NCI scientists defined long-term survivor as those who lived over three years while in the analysis which involves the p3 trial they chose those who lived over five years as long-term survivors. It is obvious that NCI set a higher bar to evaluate the results on the p3 trial.
Glioblastoma Molecular Characteristics and Immune Microenvironment Associated with Survival Outcomes in Patients Treated with Dendritic Cell Vaccination
https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE249282
Long-term survivors of glioblastoma: Tumor molecular, clinical, and imaging findings
https://academic.oup.com/noa/article/6/1/vdae019/7603818
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172924113
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Member Level
Re: theorysuit post# 707223
Saturday, July 20, 2024 11:40:20 AM
Post#
707232
of 707233
There are very good reasons for breaking out the cost of building a CDMO and not having it a part of the company developing the drug and that goes to risk and what happened to Dendreon, in this exact same space. Their burn rate is relatively low in this period for that reason. Their deal with the regional development authority allows the facility to be somewhat self-sustaining while they seek approval, yet they still control it and can develop it in stages. Meanwhile, their facility is funded as if it is an accelerator for similar companies in the region, by the regional development authority. The regional development authority saw no problem here. Neither do I.
The fact is, the CDMO is a contract relationship. It owns NO IP. It is not valuable without that contract. It's simply a took for isolating risk and costs and managing a process with lots of expertise that is needed for key moments and a key stage. Later, when funds are not an issue, it can all be brought in house either by ending the contract or buying the employment contracts of those people out. But the reality is, the value of the CDMO is simply a measure of the costs of making the drug, with 10% on top. And the contract is cancelable at will.
The other reality is, if they did not do it this way, they would be paying many multiples of what they are paying now, to pay for another companies complete facility and likely a much higher built in profit given that that other company would depreciate all of the assets paid for and have them for any other project they took on. The reality is, small companies like this virtually ALWAYS use CDMOs, with this kind of cell based manufacturing, and this company not only has the CDMO working on its subsidized facility, but it has space to develop its own technology for automating the process, which it owns outright and which it will deploy on commercialization. At that stage, the CDMO might help to deploy and resource such a facility, but also the company can then also likely do all kinds of arrangements including set-up to manufacture itself.
The reality is, the flaskworks technology is where all the innovation and IP will originate going forward, and the efficiencies, not in hand made craft work creating the vaccines, but in closed-end, automated manufacturing of these cell based vaccines. So hiring in this manner is very efficient and well thought out and ensures they scale only when they are ready to scale, and they might decide to create a very modular corporate structure in the long run as well. We'll have to see. But they have all the tools to be very flexible and that is the best way to be when you're dealing with the kinds of potential costs and challenges that such new biotech companies face.
Bullish
BULLISH
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