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I found this online. I don't know if this referring to Americans only or globally:
According to the CDC, 1 in 5 adolescents aged 12-18 and 1 in 4 young adults aged 19-34 years are living with prediabetes.
114 million diabetics
(10.9% of the adult population)
388 million prediabetics
(35.7% of the adult population)
114+388 = an addressable market of 502 million Chinese adults
That number would be even larger since there are no stats provided about how many kids in China have prediabetes or diabetes.
Quick question: If Oramed gets FDA approval, will doctors be able to prescribe the pill to minors as well or will Oramed have to do a separate trial with minors in order to get FDA approval to prescribe oral insulin to minors as well?
That presentation just started.
West Virginia man battling ALS hoping FDA reverses decision on drug treatment
https://www.wowktv.com/news/local/west-virginia-man-battling-als-hoping-fda-reverses-decision-on-drug-treatment/
How Matt Feels & Functions w #ALS,
— AZ Latina ☮️🌊🟦 (@aVoice4ALS) December 6, 2022
which kills most in 3-5 yrs
2018 Dx
2019 #NurOwn trial - stabilized
20-21 Declined
2021 EAP - stabilized. Climbing stairs
21-22 Declined
2022 EAP - stabilized. #Walking w walker@FDACBER Act Urgently & let Matt Testify
Matt Knows #NurOwnWorks pic.twitter.com/ONv2DMFbdO
Stock Pitch World Cup(TM), Educational Panels and 49 Companies to Present at the Planet MicroCap Showcase: VIRTUAL on December 6-8, 2022
Wednesday, December 07, 2022 - 1:30 PM Eastern Time
https://www.webcaster4.com/Webcast/Page/2937/47218
Things that stood out to me about today's presentation @ the Piper Sandler Conference:
• Customer complaints for Recell are incredibly low.
• They have two indications (soft tissue repair & vitiligo) that are going in for a PMA supplement next month.
• Japan received their first stocking order for Recell in September and has already treated dozens of patients in that first month.
• Since Japan's healthcare industry is about a 1/3 the size of the U.S., it could be a 10 million dollar business in 3-4 years.
• Avita sees a big international potential of Recell being used in 20 countries, if not more. Plans in how to go about getting that done will happen in 2023.
• Their priority in 2023 is the launch for their soft tissue indication. Plans to file in December of this year. Expect approval in June 2023.
• The clinical outcome for their soft tissue repair study "was just exceptional". "We had a P-value of 025 that we had to meet or beat, and we beat it. And by beating it, that is really a healing definition."
• "Economically, the soft tissue repair market is 3-4 times bigger than the burn market. It sits in level 1 & 2 trauma centers. The synergy is rather interesting. Half of the burn centers are level 1 or 2 trauma centers. We will instantly get access to that broader indication on the day of approval and we have reimbursement. Secondly, in the level 1 and 2 trauma centers sits 25% of the burn market we don't call on." Their sales team will hit the ground running in those level 1 & 2 trauma centers that they didn't previously have access to.
• Avita will be doubling the size of their sales reps. Announcing those details in February.
• Vitiligo - They expect approval in June 2023. Estimated that it will get to market by January 2025.
• "What is most interesting to us is our most recent market research: 438,000 patient sought treatment for their vitiligo last year which is an enormous market because really none of those treatments are very effective. It happened in our trial that it was against a control and at 6 months where we had a responder group of about 80%, the control actually had a 0% responder to the standard of care today at 6 months. So, that is such a divergent outcome, we know that if we get it right, we will have a big winner...Well, ultimately this is a couple billion dollar market. You take those 438 (thousand) and you multiply them by $6,000, you get 2.5 billion."
FYI: Avita's presentation at the Piper Sandler 34th Annual Healthcare Conference starts in two minutes.
Dramatic letter from Esteban Bulrich to Joe Biden for the United States to approve a drug against ALS
https://nationworldnews.com/dramatic-letter-from-esteban-bulrich-to-joe-biden-for-the-united-states-to-approve-a-drug-against-als/
My son also. He did not progress for 14 months while in the trial. His progression began 2 months after his last injection.
— Smithstrongmom (@Smithstrongmom1) May 28, 2020
So upsetting to know there is treatments, but we can't have them.
Doors have to be opened, and it can begin NOW!
Fort Smith man losing hope after FDA denies potential ALS treatment
https://www.newsbreak.com/news/2835324206088/fort-smith-man-losing-hope-after-fda-denies-potential-als-treatment
I Am ALS and Veterans with ALS send an Open Letter to FDA Requesting an Advisory Committee Meeting to Discuss NurOwn
https://seekingalpha.com/pr/19033407-i-als-and-veterans-als-send-open-letter-to-fda-requesting-advisory-committee-meeting-to
ORMP: Data from NASH Phase 2 Study – Positive Takeaways
https://finance.yahoo.com/news/ormp-data-nash-phase-2-154500308.html
Stevens Nation Responds to FDA's Refusal to File Letter, NurOwn Recipients Call for Advisory Committee Meeting
https://www.biospace.com/article/releases/stevens-nation-responds-to-fda-s-refusal-to-file-letter-nurown-recipients-call-for-advisory-committee-meeting/?fbclid=IwAR2iG67LyxK2h8-k2qNvl4MRittIKFmOoOOOley1u5pkWXckuwvJ3gNNwbA
Any idea what caused this huge spike to the stock price? Did Brainstorm get their ADCOM meeting?
The stock is currently up a whopping 27% so far today.
@ 30:37
The Zoom replay is available of the NASH presentation.
https://touchconference.zoom.us/webinar/register/WN_dy3jzksKQA6kBKZdT5a0_g
The primary objective of the trial was to see if oral insulin was safe for patients with NASH and type 2 DM.
Fast forward to 27:43 for the results of the primary objective.
29:31 - Prof. Yaron Ilan talks about the safety profile of the product.
The secondary objective of the trial was to see if oral insulin is effective in reducing fat liver content for patients with NASH and type 2 DM.
Fast forward to 23:47 for the results of the secondary objective.
30:37 - "Within a very short period of time these patients were treated for only twelve weeks, and we already saw signs of reversal of fibrosis. This, which is, WHICH IS QUITE REMARKABLE."
Meet Jim Corbett - Chief Executive Officer, AVITA Medical, Inc.
https://avitamedical.reportablenews.com/pr/meet-jim-corbett-chief-executive-officer-avita-medical-inc
The doctors in that Zoom presentation seemed really impressed with the results. Especially when they were comparing it to other drugs.
This makes me even more confident about getting positive results in January for the phase 3 trial. The technology that showed great results in their phase 2 Nash trial is the same tech in the phase 3 insulin trial. It's just another confirmation that the technology works.
The January results can't come soon enough!
Oramed Announces Additional Positive Safety and Efficacy Data from Its Phase 2 Clinical Trial of ORMD-0801 for NASH
https://seekingalpha.com/pr/19027368-oramed-announces-additional-positive-safety-and-efficacy-data-from-phase-2-clinical-trial-of
The Nash Zoom meeting has started.
So far, I found out that they are treating Jay with hyperbaric oxygen therapy and a biological skin substitute that was placed over the wounds. That is a temporary biological dressing that will eventually be removed. His wounds will then be reevaluated over the next few days.
He also is being treated with donated cadaver skin.
There have not been any reports yet that he's being treated with Recell yet. I hope that changes though since that would be millions of dollars in free advertising and possible new investors.
The reason I bought Avita stock was because of a news story about that little blond British boy Zed with the 2nd degree scald burn on his chest. That before & after pic sent me down the due diligence rabbit hole and I ended up buying stock @ $1.15 (I think it was a year or two before their phase 3 results).
AVITA Medical® to Host Investor Webinar Briefing
https://seekingalpha.com/pr/19025793-avita-medical-to-host-investor-webinar-briefing
Just a reminder:
Oramed to Host Webinar Highlighting Detailed Safety and Efficacy Data from Its Positive Phase 2 Clinical Trial of ORMD-0801 for NASH
The presentation is tomorrow @ 11:00 a.m. EST
To register for the event, please click the following link:
https://touchconference.zoom.us/webinar/register/WN_dy3jzksKQA6kBKZdT5a0_g
The live and archived webinar of this event may be accessed on Oramed's website under Events and Presentations.
I found out that Jay Leno is currently being treated with hyperbaric oxygen therapy and a biological skin substitute that was placed over the wounds. That is a temporary biological dressing that will eventually be removed. His wounds will then be reevaluated over the next few days.
There was no mention of using Recell in the video but maybe that could change after the reevaluation. Here's a link to the video:
The Aussie stock closed up 6.64% last night.
Plus, if he does get treated with Recell and has good results, he will probably talk about it in interviews, which will translate to positive exposure for Avita and probably a bump to the stock price.
Great gains so far today!
I guess we are going to see a lot more of the same the closer we get to the phase 3 results in January.
I just read today that Jay Leno just burned his face:
BrainStorm Vows to Push for Adcomm Meeting on NurOwn in ALS
https://www.biospace.com/article/brainstorm-vows-to-push-for-an-adcomm-meeting-on-nurown-in-als/
That article (that has no author) reminds me of that fake report that shorters put up on a small website called Parallax Bio that only had 600+ subscribers. That single article caused Oramad stock to plummet from its $30 high. After the damage was done, the report was removed from the website.
Here was a story about it.
AVITA Medical, Inc. (RCEL) Q3 2022 Earnings Call Transcript
https://seekingalpha.com/article/4556261-avita-medical-inc-rcel-q3-2022-earnings-call-transcript?utm_medium=referral&utm_source=conferencecalltranscripts&utm_medium=referral%27%20target=
.....
Mike Hensen & Michelle Lorenz going LIVE @ 5:30pm central time to talk about FDA's heartbreaking decision not to consider NurOwn BLA. Go to the No More Excuses ALS Facebook Group to watch.
https://www.facebook.com/groups/NOMOREEXCUSESALS/
Just a reminder that AVITA Medical will host a conference call and webcast today at 1:30 p.m. Pacific Time (Friday, November 11, 2022, at 8:30 a.m. Australian Eastern Daylight Time) to discuss its financial results and recent highlights.
The live webcast of the call may be accessed by visiting the Events section of the AVITA Medical’s website at ir.avitamedical.com. A replay of the webcast will be available shortly after the conclusion of the call.
BrainStorm Cell Therapeutics Receives Refusal to File Letter from FDA for its New Biologics License Application for NurOwn for the treatment of ALS
https://www.prnewswire.com/news-releases/brainstorm-cell-therapeutics-receives-refusal-to-file-letter-from-fda-for-its-new-biologics-license-application-for-nurown-for-the-treatment-of-als-301673753.html
NurOwn Continues to Show Benefit in Rapidly Advancing ALS
https://alsnewstoday.com/news/nurown-continues-show-benefit-rapidly-advancing-als/
NurOwn Stromal Cell Therapy Continues to Show Positive Data in Less Severe ALS
https://www.neurologylive.com/view/nurown-stromal-cell-therapy-continues-show-positive-data-less-severe-als