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I'm haven't and I'm not arguing against your opinion of him not being the best at presenting.

That's just a motivated assumption. People don't like his presenting so they are attributing the drop to it.

When I stepped out the house this morning it started raining. Did I cause it?

Besides, he spoke less than anyone else on the webcast so...

Only if you promise to stop beating the 'duncan shouldn't present or give interviews' drum every time he does.

deal? ;)

The fastest way to make a meaningful dent in the diesel generator market whilst at the same time taking the company towards profitability is starting at the top and going after the big companies. They use the most, they have the resources to bridge the change and they also stand to gain the most on the public relations standpoint.

Get them on board first and then worry about meeting the needs of the smaller outfits who only need one and want to load it in to the back of their transit.

note that the Panasonic 5kw tower doesn't have fuel flexibility as it can only use hydrogen

AFC have done well with the size. Panasonic announced the launch of a 5kw tower late last year. Half the power yet barely any smaller.

https://news.panasonic.com/global/press/data/2021/10/en211001-4/en211001-4.html

SO is the result of the Woodford situation which itself had nothing to do with 4D’s financial strategy.

Even if you knew how much someone has invested, the average price they hold at and what percentage of their portfolio it constitutes, none of that would actually tell you whether or not what that person is saying is correct and/or well reasoned.

Single strain would probably be more relevant ;)

Key bit for me was his reiterating something that he has alluded to before, namely that for all their candidates what they see on the research bench is translating into the clinic. It's a great thumbs up for the microRX discovery platform and underlines the relevance of the microbiome + the translatability of the single strain approach that they've taken.

*ici refractory not ice

It’s possible that there might be an avenue for blautix to go through the fda’s fast track pathway but I expect that would hinge on whether or not the fda considers its potential to treat ibs m as enough to consider it as meeting an unmet need. If it could go down the fast track route it would still need to do phase 3 before hitting the clinic commercially but the contact with the fda would be more frequent and quicker, which is what shortens the overall length of time required to conduct a phase 3 trial and get it to clinic.

mrx0518 on the other hand should be a good candidate for the fda’s accelerated approval pathway using a surrogate endpoint. Accelerated approval of drugs and biologics is only considered for serious, life threatening conditions. In oncology the surrogate endpoint would typically be tumour shrinkage but there is wiggle room there on the exact endpoint and I think that wiggle room would be required for mrx0518/keytrdua combo in ice refractory rcc patients. Whilst the likelihood of tumour shrinkage in such patients is not impossible, it's not the norm. That’s why steady disease control is considered an important and clinically meaningful endpoint in this cohort. Whether or not it’s an endpoint that the fda would allow for accelerated approval I'm not sure but I imagine it should be given the alternative to halting progression and keeping quality of life steady is continued worsening to the end.

This is the up to date list of drugs that are currently on/have been through the accelerated approval pathway. You’ll note how many are for cancer.

https://www.fda.gov/media/151146/download

One thing to note about the accelerated approval process is that congress is currently examining it and considering a raft of changes. I won’t regurgitate everything they are looking at but one aspect of note is that some have proposed changing rules around the phase 4 confirmatory study. Currently, before accelerated approval is given a company needs to design and agree details of the confirmatory study with the fda but they don’t need to actually start the study before the drug is in the clinic. The change that some are proposing is to require that the confirmatory study actually begin before approval is granted. This would obviously have the effect of slowing down the speed at which approval can be granted and drugs can be put in the clinic, something that a lot of patient advocates are understandably against.

https://www.pharmexec.com/view/fda-congress-re-examine-accelerated-approval-program

Steve, it wasn't a buy.

UT = uncrossing trade

Surprised no one has mentioned the military.

We obviously know afc and the army have been/are in close contact and I'm pretty sure they would have a lot of potential uses for for generators of this size.

"Overall it’s 4 out of 47 so far."

Factually incorrect. It's 4 out of 16 renal cell carcinoma patients. The rest of the 47 are in different cancers arms and they haven't reported anything on those yet.

Honestly, if you are going to spread nonsense at least make it something that requires more than two seconds and half a brain cell to debunk.

Whilst I know you are right Porky, on principle I don't believe in dumbing down. I think it's important people actually understand what it is they are putting their money in.

Each to their own of course but the only way I would invest in something I don't actually understand is if I was putting my money into a fund or trust etc and delegating that responsibility to the person managing it.

There is a difference between response and disease control. So when they say 0% response they are technically correct but it's a naive and or blinkered argument that they are making.

For RCC patients who have had multiple lines of therapy and stopped responding, disease control is considered important and clinically meaningful.

I honestly find it quite incredible that some are questioning the relevance and clinical meaningfulness of stable disease control in patients where everything including the last line of therapy has stopped working.

This is why stable disease control is considered a relevant primary endpoint in RCC patients who have had multiple lines of therapy. Dr Sumanta Pal is a highly regarded kol in genitourinary cancers.

https://www.healio.com/news/hematology-oncology/20211112/tivozanib-improves-disease-control-in-advanced-renal-cell-carcinoma

“The likelihood of measurable renal cell carcinoma tumor response diminishes after [two or more] lines of therapy, and the clinical relevance of prolonged stable disease is increasingly important,” Pal and colleagues wrote. “Previous research in advanced renal cell carcinoma suggests that improvement in disease control rate may correlate with longer-term survival and underscores the contribution of stable disease to patient-level outcomes.”

"The findings suggest disease control is “an important endpoint” for patients with relapsed or refractory renal cell carcinoma receiving third- or fourth-line treatment, researchers added."

https://www.merck.com/news/mercks-keytruda-pembrolizumab-significantly-improved-disease-free-survival-dfs-versus-placebo-as-adjuvant-therapy-in-patients-with-stage-ib-iiia-non-small-cell-lung-cancer-nsclc-r/