"enough wasted time for a while" - exactly!
"I note Phiefer, who only ever partakes in a slim section of the topic, does not touch the damming stuff and claims victory. Bizzar. All you proved was the flip-flopping sloppiness of CYP."
Looking at that sentence:
1. ever wondered why the asx stock codes only contain 3 letters? p (1) + f (2) + e (3) + i (4) + f (5) + e (6) + r (7) is way too hard for your average "investor" it seems. "Investors" would end up with a portfolio as consistent as some of the stocks they represent.
2. "only ever partakes in a slim section of the topic" - all the correspondence on these threads suggest otherwise. The... silent... as well as the verbal... readers... would remember the previous back and forth, which conveniently just re-starts. This "topic" and truly "damming stuff" would require an approach that is well beyond the time I am willing to dedicate to HC. And the alternative, last time I checked I am not Henry the veterinarian and the man behind the bar is certainly not Lucy, therefore don't expect me to make a video for you to watch every morning, covering the "damming stuff" that has already been covered.
Sorry, but there won't be a poor man's version of "50 First HC Posts" (gotta love these "strage analogies").
Also, the sense of entitlement that people on HC seem to have, amazing. It is not my duty to hold someone's hand when they wake up in the middle of the night, mattress soaked with cold sweat, screaming "Coffee, Ross, US, FDAAAAAAA" and chuck a hissy fit. You won't see me holding your hand, calming you down and tucking you back in. That's what you have your FB group for.
3. I leave claiming victory on HC
to the ones that need it. I guess it can get really lonely on that high horse.
4. Why throwing mud at "Bizzar", the seventh studio album by Insane Clown Posse, which was released back in 2000?
5. "flip-flopping sloppiness of CYP" - this is where the "long-winded-speeches" start. Sure, the more content a post contains, the easier it is attempting to pin-point a sentence, take it out of context to suit your needs. Or you present a one-liner, keep it as vague as possible so that you can back-peddle when needed, because hey, that's not what I said, right? And even if that one line is stretched into 10 on occasion, the content remains the same. (I bet you know what comes next - an analogy) Just like you can try and stretch your cheap booze into a six pack. Whilst it now may look like more to you and your "friends", it is still nothing but a cup of cheap booze to everyone else.
I will highlight a few words (
bold) along the way:
“When we
started planning we didn’t have aparticularly strong view on where we would conduct the study. We were keen to deliver it here in Australia, but we knew this would be difficult because the target patient population is so small, so we were quite open to extending the trial overseas as well.
“We
picked the UK after speaking to a number of regulatory authorities in the UK, Europe and in other regions. We found that the Medicines and Healthcare Regulatory Agency (MHRA) was particularly helpful and
very pragmatic in terms of what they required from us to be able approve the clinical trial in the UK. They provided very clear guidance about what we needed to do in terms of pre-clinical testing. This led us to the conclusion that
we had a good chance of getting the trial approved in the UK quite quickly, compared to some other countries where the journey may not have been quite as smooth."
https://webarchive.nationalarchives.gov.uk/ukgwa/20181102172021/https:/www.nihr.ac.uk/news-and-events/features/behind-the-research/Stem%20cell%20research%20in%20GVHD.htm
https://files.cynata.com/399/16.09.19.UK-Regulatory-Authority-Approves-GvHD-Clinical-Trial.pdfSo, despite talking to other regulatory authorities, they have decided to conduct the world first clinical trial with an allogeneic iPSC-derived product in the country where they saw a "good chance of getting the trial aproved [...] quite quickly, compared to some other countries where the journey may not have been quite as smooth" - and it worked out.
They have still continued their discussions with other regulatory authorities and when the 21st Century Cures Act (Cures Act) was signed into law on December 13, 2016, another opportunity presented itself given the potential fast-track provisions it provides (which be very relevant again shortly - 2021/2022, watch this space):
https://files.cynata.com/262/17.04.19.Cynata-Advances-to-Pre-IND-Meeting-with-US-FDA-1.pdf
https://files.cynata.com/282/17.07.05.FDA-Meeting-Provides-Clear-Path-for-US-Development-Plans.pdf21st Century Cures Act
The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.
The law builds on FDA's ongoing work to incorporate the perspectives of patients into the development of drugs, biological products, and devices in FDA's decision-making process. Cures enhances our ability to modernize clinical trial designs, including the use ofreal-world evidence, and clinical outcome assessments, which will speed the development and review of novel medical products, includingmedical countermeasures.
https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-actBut, for a few months now the plans for CYP-001 in GvHD were no longer in Cynata's plans to make alone:
https://app.sharelinktechnologies.com/announcement/asx/ed3a6b50b74778d6f7c4839e02401c72
https://app.sharelinktechnologies.com/announcement/asx/e87f20bfeb9ed1b21deaf4f8d7d61f1eCynata however continued discussions with the FDA of course, even while having recruitment centers in the AU and the UK looking for patients to enroll:
Why? Because the USA is "the world's largest healthcare market" and an open IND in the US is a door opener to advance a clinical trial for CYP-0XX based on pre-clinical studies (of which we now have many) in other indications, given the same underlying CMC.
https://app.sharelinktechnologies.com/announcement/asx/3bc1dc96a605e0a6e28a592c7d1cb2d8CYP-001 in GvHD however (at the time) was now up to FF, and they were very clear what and where they want to start:
Ken-ichiro Hata also in 2018:
"There are many walls that must be overcome in order to make organs from iPS cells, but research and development of cell therapy using iPS cells is progressing steadily. CDI also supplies iPS cells to the Australian regenerative medical venture in the Fujifilm Group and contributes to the world's first iPS cell clinical trial in the UK. This is to inject a mesenchymal stem cell (* 3) made from iPS cells and treat it for patients with complications that occur after leukemia bone marrow transplantation.
And Fujifilm will do the same clinical trial in Japan, as a company in 2019 for the first time. If approval from the country is obtained, I would like to sell it to medical institutions as a formulation."
http://brand.fujifilm.co.jp/healthcare/interview/interview3.htmlArticle also mentioned here:
https://hotcopper.com.au/threads/going-forward.4444981/page-1391?post_id=40421146Also in 2018:
"Fujifilm announced on Wednesday that it will establish a facility for production of artificial pluripotent stem cells (iPS cells) for treatment in Wisconsin State, USA. Investment amount is about 2.5 billion yen. It is intended to accelerate the development of regenerative medicine products using iPS cells and to operate it in FY 2019.Fujifilm plans to apply for a clinical trial (clinical trial) for obtaining approval of transplantation medicine by iPS cells from the country
in Japan during FY 2018. We
plan to conduct clinical trials in the United States."
https://www.sankei.com/smp/life/news/181220/lif1812200031-s1.htmlArticle also mentioned here:
https://hotcopper.com.au/threads/going-forward.4444981/page-357?post_id=36926939Since 30 September 2021, we know that my speculation based on articles, Tweets and announcement at the time didn't now happen:
https://www.asx.com.au/asxpdf/20210930/pdf/4512y73m0v2lh5.pdfInstead, Cynata is now picking up on the discussions they had pre and during FF for obvious reasons since it is now Cynata's call again where the next chapter of CYP-001 in GvHD is to be written.
Especially since the FDA CRL received by MSB, highlighting the very reason why Cynata was invented in first place - and no, it is not because of the 60% GP that 3D may present:
https://www.fda.gov/media/143337/downloadAlso covered here:
https://hotcopper.com.au/threads/2021-year-of-the-boom.6097217/page-188?post_id=53709439He is clearly NOT concerned about the cost.
And your constant "MSB has 3D", sure, MSB has had access to 3D since 2015, yet, when they could have introduced the "new product", which would have also provided "comparable" data with previous studies and the original product, scale-out appeared to have been the option of choice.
Also covered here:
https://hotcopper.com.au/threads/the-cymerus-process.5624138/page-41?post_id=47468574I have mentioned the Cymerus advantages I see here:
https://hotcopper.com.au/threads/the-science-will-do-the-talking.5651596/?post_id=47693506Except I wrote "less irrelevant" instead of "less relevant".
Picking up on the post and considering:
1. FCDI will be our new CDMO
2. The expansion of Cynata's iPSC-MSC happens largely on the iPSC-level:
https://www.fujifilmcdi.com/conference/isscr-2021-virtual/
https://www.fujifilmcdi.com/cdmo-services/Add to that the nature article and this statement here in particular:
Based on the existing banking strategy, approximately 9 × 10^4 vials, each containing 1 × 10^6 iPSCs, can be generated from a single iPSC line. At the current processing scale, a single vial of 1 × 10^6 iPSCs is capable of giving rise to 3.2 × 10^10 MSCs on average, while the entire iPSC bank has the capacity to generate 2.9 × 10^15 MSCs, or 29 million clinical doses (each containing 1 × 10^8 MSCs).
https://www.nature.com/articles/s41591-020-1050-xAlso covered here:
https://hotcopper.com.au/threads/the-cymerus-process.5624138/page-6?post_id=47355738The thousands of treatments from one donor has been mentioned by MSB supporters many times, including here:
https://hotcopper.com.au/threads/you-wanna-play-with-fire.5360989/page-52?post_id=44265282That has been the subject of previous discussions, where based on a statement made by SI I said it doesn't add up for GvHD in adults, see here:
https://hotcopper.com.au/threads/ann-quarterly-activity-report-appendix-4c.5358988/page-53?post_id=44268256Don't get me wrong, CYP will eventually need a viable solution to make the Cymerus process more competitive when it comes to time and cost, however, lets start walking before we go for the 100m sprint, shall we?
6. "Sloppy is having press releases, trial information, and even its own website being incorrect which I've provided links for." - Sloppy is showing up to an exam and failing with the first two questions: your full name and today's date. Just because you have trial sites trying to recruit patients, doesn't mean that each site can actually enrol patients for this study.
I found the following graffiti in a public toilet up north:
Everyone knows, the public toilet is the place where you can find great wisdom. Of course I started to panic straight away and ran home to see if that is true.
I stumbled across these presentations here:
https://cdn.ymaws.com/www.casss.org/resource/resmgr/MWDG/2016_MWDG_BrunelleJoslyn.pdfSurely, that must have been an intern on her first day putting that up, I mean, the public toilet gospel wouldn't lie, right?!
https://www.linkedin.com/in/joslyn-brunelle-ph-d-b67637aThen I realised, CYP hasn't filed a rolling BLA, CYP hasn't even conducted a clinical trial in the US, CYP hasn't even filed an IND in the US. I concluded that the FDA will be just fine.
No doubt, there will be another one-liner coming, or perhaps a one-liner-content-cheap-booze-stretch-10-liner. Don't waste your time, because I couldn't care any less what the man behind the bar writes or thinks. I am capable of doing my own research and make my investment decisions accordingly. Someone that is not capable of researching his own stock that he is invested in, I mean, what good is it to take that opinion on board on a stock he is not invested in.
And it has turned into a "50 First HC Posts" afterall. I apologise to all the... silent... readers... at home for having to put up with a very repetitive post and I promise to leave it at that. Also, I am not willing to waste any more time on this... debate...
The above is mostly my opinion, based on information that is publicly available. I have provided links where possible. That however doesn't mean that every statement with a link is correct as certain statements can be subjective and as such being taken and understood with my investment in mind. It is far off from being financial advice in any sort of shape and form.
(20min delay)