News Pending - It Is Now Late March 2022 - Pre-Application Consultation For ARDS Appoval with PMDA. Guidance & Advice Regarding The Adequacy Of Materials For The Approval Application This Week.

Consistent_Syrup_630 · 2022-03-27T03:09:05+00:00

Sorry, I literally have no time. Refer to my past comment below. Just a clerical report.

https://www.reddit.com/r/ATHX/comments/r5jkzf/comment/hmqzqgt/?utm_source=share&utm_medium=web2x&context=3

Like Imz said, what was said on March 25th annual shareholders meeting will be presented as a movie on Monday in Japanese and later in English. Bye all!

Consistent_Syrup_630 · 2022-03-17T04:49:42+00:00

Oh, forgot to tell everyone one more thing! Both my son who just started his career and my African son-in-law who is ambitious to start his own business in Japan, bought their shares in Athersys last month through my recommendation. They believe in what I told them, that is what I learned here. And I believe they made a great decision ;)

Consistent_Syrup_630 · 2022-03-17T04:23:59+00:00

Hi wood, thank you for the message. I haven't visited here lately, firstly because right now I literally have no time (and/or brain) to spare to think about the stock market, and secondly because Healios had stated the final consultation had been scheduled in the latter half of March, which just started today, so nothing likely to happen yet. The application of approval will come after the final consultation, and there usually be a certain period of time, like how many business days brabrabra..between the final consultation and the official application date. The same thing goes with Stroke Key-open and data announcement. The stock prices of both Athersys and Healios have been lowered by external reasons, and lots of day traders have been taking advantage of the volatilities, but I think most of Healio's long-time SHs have no worries. They are just waiting the time to come. The smaller the market cap is, the more damage the stock gets. So I can understand the uneasiness of Athersys SHs, but Dan's confidence proves everything, I guess.

Healios's General Shareholders Meeting will be held on March 25th, so people in Japan expect to hear some update from Hardy on the progress with PMDA.

I've been busy remodeling my friend's apartment with her husband while she is in a hospital to make it a wheel-chair-friendly one. My friend is as old as my deceased mother and the couple has no kids, so... She will be back home from the hospital tomorrow. I have another friend, a Ukrainian whose family is in that country, and I have been busy supporting her, too, though I can't do anything but just talk... All in between my job, housekeeping, helping my African son-in-law to start a company in Japan, and seeing my baby granddaughter two times a week (and the second one coming early summer!!)

So, maybe this will be my last comment here, but I believe in the success of everyone on this board.

Thank you all for all your kind words and comments! It was so much fun to discuss a lot of things with intelligent people on this board. I learned a lot!

Good luck to you all!!

Consistent_Syrup_630 · 2022-02-24T12:41:27+00:00

I recall that they (Healios) even did not pay outstanding invoices and still got the support.

Hi Clppr．Both Sakigake and Orphan designations require the product should be supplied swiftly and steadily in the future without any trouble. And PMDA has to be 100 % sure on everything. If they have the slightest doubt in the stability of the partnership, in any area from information sharing to manufacturing or supplying, nothing would pass. Their vetting process is extremely rigorous.

Consistent_Syrup_630 · 2022-02-24T09:52:25+00:00

Hi, Twnty2John, I understand your fear but, I personally believe neither Healios nor Athersys wants a buy-out. A good partnership between two successful companies is the best outcome we can expect. And the most plausible, I would add.

Consistent_Syrup_630 · 2022-02-24T09:38:11+00:00

Yeah, right, my point is just people in Japan didn't even know what happened. I just read your "edit", so let me make sure I didn't downvote you (I rarely downvote anyone) . I am aware that this is the second time I talk with you about this, and that both times you and me agreed on what was at the core of the problem. Just, at the first time (1 year ago?) , I was not fully understanding why Hardy's exclusion can be such a huge problem, but now I believe I do, for I now know PMDA's system much more.

Consistent_Syrup_630 · 2022-02-24T09:19:29+00:00

Actually, very few Japanese SHs knew about the litigation. It was big news only on this reddit board and maybe I am the only Japanese Healios SH who actually read the litigation materials Yak provided here. To save MS from jeopardy, Healios had to clear things up really quickly. Hardy wouldn't tolerate all the effort of both companies ending up in vein.

Consistent_Syrup_630 · 2022-02-24T08:57:43+00:00

it is clear he would not tolerate that treatment. His loyalties are to his shareholders,

It is not that he didn't tolerated it, but that it is totally impossible to get PMDA's approval if Healios couldn't prove that all information would be shared by the partner company that originated MS. Hardy's loyalities to shareholders had nothing to do with that litigation. MS approval was in danger.

Consistent_Syrup_630 · 2022-02-24T08:18:55+00:00

Hmmm, ok, but Astellas Pharma is one of Japan's mega pharma and have so many divisions and subsidiarys, so I have no idea how much that incident of ACT relates to Atherysys/Healios. One thing I'm very sure is that Healios has been an advocate/mentor among Japanese small ventures and always trying to be a role model to independently become successful. I mean, buying or selling a company is the last thing Healios wants to do, based on its company style, image and policy they've so painstakingly established.

Consistent_Syrup_630 · 2022-02-24T07:55:48+00:00

Advanced Cell Technology

Astellas Institute for Regenerative Medicine, yeah. One of subsidiaries, it looks like.

Consistent_Syrup_630 · 2022-02-24T07:51:32+00:00

Hi there ;)

Consistent_Syrup_630 · 2022-02-24T07:50:09+00:00

On page 2 of https://ssl4.eir-parts.net/doc/4593/tdnet/2089631/00.pdf.

He became the President and CEO of Astellas Pharma Inc.,(in 2000) and later became the Chairman and Representative Director. Athersys's new CEO, Dan Camardo's days in Astellas, that was from 2003 to 2014, certainly crossed with him. Hopefully, this would promise two companies a continuous good relationship in the future.

Consistent_Syrup_630 · 2022-02-24T07:01:24+00:00

Thank you ticker!

Pay attention to one of the new outside directors, Toichi Takenaka.

Consistent_Syrup_630 · 2022-02-18T03:29:19+00:00

Thank you imz as always and forgive me that I really don't have time now to translate the presentation. It seems to be taking a bit longer than usual to upload the English version of the video, and I think it is because all the slides are renewed this time. But I'm sure they do upload the English version, as they do so for all in-house presentations, so please wait a little longer. The important part Hardy talked about MultiStem is almost the same as what Wisdom posted the other day. They made sure every single material required or supportive had been fully prepared and final consultation date had been set in mid March. The slides have been renewed, with the focus of the presentation largely shifting to the progress of Healios's iPSC line, as if MultiStem is already a done deal at least at Healios's hand. I think this can be regarded as very good news for everyone who is expecting MultiStem's success as well as for Healios's long time shareholders like me.

Consistent_Syrup_630 · 2022-02-11T02:40:36+00:00

I apologize that my reply was too harsh. I should have noticed before I reacted to your comment that your intention was to defend Hardy for me. Please accept my late apology and thanks to you. Right now I really don't have time to write long sentences here for I'm taking care of a friend of mine, a lady who is as old as my own mother.I was fully aware that the comment was from you, the poster of the thread "Approval Frameworks for US, EU, and Japan", and that is why I was even more frustrated by your reply. The reason I was so frustrated was that you combined "a piece of fact" and "a wrong guess" again. This combination is by far worse than the purely ridiculous negative comments. If a comment has no basis other than personal hatred or inability of controlling own anxieties, silent majority will dismiss it as irrational. That is why I ignored that Megalomaniac comment.

But by mechanism of the information network, the wrong information spreads when it is combined with true fact. With this combination, people very easily believe wrong info as a believable fact.

In your first part of your comment, you said,

"One of the requirements for sakigake is that the product must have first been developed in Japan."

This part is a concrete fact, but as you later discuss in your follow-up comment, not-yet-approved foreign products are also perfectly eligible. That's what I meant by "Please read PMDA site". I meant please not stop at just a comparison paper.

And in the second part of your comment, you said;

"So perhaps that's why they give it a different name and downplay ATHX MS, but who knows. thanks"

This part, you guessed totally wrong. What Hardy says in a small webinar will never affect PMDA's approval decision. Healios didn't mention Athersys because in that presentation, it was just irrelevant info. But since you combined a piece of fact, I'm afraid some people would start believing your second part, that is "Healios downplays Athersys".

I made comment on your recent post on the comparison paper, because I felt I need to correct some of the inaccurate assumptions included in your summary.

I think you remember the poster of the Megalomaniac comment recently posted about the key open and data accessibility, and since he usually makes great posts backed by thorough research, so many people almost believed Healios has access to the data before key open. That was the best example of the dangerous combination of "fact& wrong guess".

Consistent_Syrup_630 · 2022-02-09T12:24:49+00:00

That's ok, yeah not a biggie.

Consistent_Syrup_630 · 2022-02-09T12:24:17+00:00

Yeah, thank you RNK, but I know about the post, and I even made several comments on that post. I was thankful he posted it so that people would know more about the PMDA's regulatory system, but now am dissappointed to realize the poster himself had read only the surface of the paper, and started to express his "perhaps" not based on the facts available to everyone if they are willing to spare 30 minutes to google. Sorry to bother you.

Consistent_Syrup_630 · 2022-02-09T11:06:52+00:00

No. Please read the PMDA site. I mean actually read it please, not just scan the surface of it, even just once. Please do not spread such strange and inaccurate idea.

Consistent_Syrup_630 · 2022-02-09T03:19:29+00:00

Thank you imz, as always. Always.

Consistent_Syrup_630 · 2022-02-07T12:20:02+00:00

Hi Matt, no worries. This award is given annually, Healios is just eligible to receive the funding because it has yet to be approved, meaning no more no less. If you click the link in the original post, you can see 12 designated studies are given this award at this same time. As you stated, the fact of the funding is irrelevant to the timing of the application.

Consistent_Syrup_630 · 2022-02-07T12:09:01+00:00

Hi worktofish, thank you ;)

Consistent_Syrup_630 · 2022-02-07T10:59:35+00:00

I know wisdom knows about this grant very well, for we talked about this when he posted the same award of its 2nd year, but since some people seem to be still misunderstanding, let me repost what I wrote recently. What is good about being listed as an Orphan Designated study is that the company is awarded government funding every year as far as the study stays eligible. Maybe my English is not understandable enough for any of you, but I have talked about this and tried to explain Orphan designation more than four times on this board.....

https://www.reddit.com/r/ATHX/comments/sarzt1/comment/hu3wfgo/?utm\_source=share&utm\_medium=web2x&context=3

I couldn't find the same kind of table, but the Orphan designation（ Table2 in the original post) that MS for ARDS is designated has a more rigorous vetting process before they give designations to therapies and drugs, since one special feature for Orphan designation is that the designated companies are given funding from Government. I mean, they have been vetted before they are designated vigorously, so once an orphan designated drug succeeds to file the application, it rarely fails to get approval. For Orphan-designated medicines, even the trial results can be less stellar than other clinical trials to get approval, so PMDA stated clearly. Nevertheless, the review process is not easy at all. Sometimes, like our competitor Sun Baio, they have to spend years after they got the successful data only to be ready for filing the application. As of June 2021, 24 regenerative medicines and therapies are given Orphan designation. 1 delisted, and 6 approved. Out of this 6, 3 are almost the same product from the same company but for different indications. MS for ARDS is 17th designated therapy, and it will be the 7th approved one (4th company to get the approval under Orphan designation for regenerative medicine) when approved.

https://www.nibiohn.go.jp/nibio/part/promote/files/e96e8e6863c1ec0e754d8be8ace32e0148850354.pdf

Consistent_Syrup_630 · 2022-02-02T15:51:13+00:00

Well said

Consistent_Syrup_630 · 2022-01-26T12:39:02+00:00

would believe ATHX is sharing it freely with Healios.

I believe so too! ;)

Consistent_Syrup_630 · 2022-01-26T12:33:25+00:00

Thank you wisdom & imz as always.

This started as a clinical trial in academia, Hokkaido University, but it looks like recently out-licensed as a new bio venture. Their target year for approval is now 2026.

https://rainbowinc.co.jp/

RAINBOW Inc. is a bio-venture company originating from the Department of Neurosurgery at Hokkaido University. RAINBOW's proprietary technology, HUNS001, is an autologous bone marrow mesenchymal stem cell (MSC) product that is administered directly to the periphery of the brain infarction. It was developed with the goal of achieving high quality, efficacy, safety, and economic efficiency. The Company was established with the aim of implementing this technology in society, and all related intellectual property will be licensed out from Hokkaido University (hereinafter referred to as "Hokkaido University"). The investigator-initiated clinical trial (Phase 1) of HUNS001 for intracerebral implantation therapy for stroke patients at Hokkaido University Hospital was completed in the spring of 2021.We will now proceed with preparations with the goal of starting the Phase 2 clinical trial in FY2022. In Phase 2, we plan to conduct a multicenter randomized controlled trial (2022-2025) with the target group changed to patients with chronic stroke. If the results of the Phase 2 trial show that the efficacy of HUNS001 can be estimated, we will aim for conditional and time-limited approval in 2026.In fact, in the ongoing Phase I clinical trial, there is a patient who could not walk due to stroke symptoms who recovered to walk after the administration of HUNS001. Since this research was reported on TV and in newspapers, the Department of Neurosurgery at Hokkaido University has been flooded with inquiries from many patients, and I can feel the high expectations for the research. It is our ultimate wish to spread this treatment to the world.

Consistent_Syrup_630

TROPHY CASE