Sunday, April 17, 2022 12:06:05 AM
$CAPR here’s a recap of some things happening behind the scene. This is all public information but if you piece them together, things start to make a bit more sense on current trial delay for Hope 3
1. Ppmd has been working to update guidance to fda specifically for cber - which is the more relevant part of fda for Capr - this has been in motion since June 2021.
2. Linda is part of one of the working groups (guess which one - cardiac!) https://www.parentprojectmd.org/wp-content/uploads/2021/07/Duchenne-Guidance-Working-Groups-2021.pdf
Which is likely to make the case that preserving hear muscle in dmd patients is critical for longevity. Don’t know if Paulson as a hire is tied to this but his cardiac background certainly doesn’t hurt. Cap-1002 has shown stat significant results in ckmb and ejection fraction. If the ole data is showing similar trends, more power to us.
3. Connect this piece with the fact that ppmd held a conf few weeks back with 80 cardiologists. Both fda and nih were there. Paulson was there from Capr. What’s the outcome from this? There is a committee that got set up which will provide recommendation to industry on how to monitor heart health for dmd patients in trials. All of this bodes well for us.
4. So what does this mean for Hope-3. This is speculation but imo Hope-3 is on hold until this guidance is complete. If you talk to ppmd (Pat Furlong) any amount of time, in the first min or so, she will tell you how ppmd is fully supporting Capricor. They are pushing cap-1002 hard since patients need access to drug. Pat knows califf very well. Pat point blank told me that gene therapies can make patients live longer but if the kid cannot bring his hand to his mouth after age 4, it’s pointless. Guess who has got stellar data in PUL 2.0.
5. So if you put all of this together, this has got to play on current timeline of Hope-3 as well the type of trial Hope-3 is in the current format. There could be a push happening to get fda to give a nod to Capricor to file a bla or Hope-3 endpoints might be getting modified to be more favorable for Capricor.
6. There are a couple moves I’m expecting in near term from ppmd which will make this thesis only stronger. Current state, the stock price is complete fake news imo.
Recent CAPR News
- Capricor Therapeutics to Present First Quarter 2024 Financial Results and Recent Corporate Update on May 13 • GlobeNewswire Inc. • 05/06/2024 01:00:00 PM
- Capricor Therapeutics Announces Positive Type-B Meeting with FDA for CAP-1002 Program for Duchenne Muscular Dystrophy • GlobeNewswire Inc. • 04/24/2024 01:00:00 PM
- Capricor Therapeutics to Present at Upcoming Investor Conferences • GlobeNewswire Inc. • 03/21/2024 12:30:00 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/11/2024 12:30:52 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/29/2024 09:06:15 PM
- Capricor Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update • GlobeNewswire Inc. • 02/29/2024 09:05:00 PM
- Capricor Therapeutics Announces Upcoming Type-B Meeting with the FDA to Discuss Commercial Manufacturing Planning with an Aim to Expedite BLA Pathway for CAP-1002 in Duchenne Muscular Dystrophy • GlobeNewswire Inc. • 02/27/2024 01:30:00 PM
- Capricor Therapeutics to Present Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Update on February 29 • GlobeNewswire Inc. • 02/22/2024 01:30:00 PM
- Capricor Therapeutics Announces Manufacturing Scale-Up of CAP-1002 Production at New San Diego Facility as it Continues Plans Toward Commercialization • GlobeNewswire Inc. • 02/20/2024 01:30:00 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 02/16/2024 10:04:29 PM
- Capricor Therapeutics Announces Collaboration with the National Institutes of Health for Clinical Trial of Novel Exosome-Based Multivalent Vaccine for SARS-CoV-2 • GlobeNewswire Inc. • 01/24/2024 02:15:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/11/2024 02:00:12 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:15:51 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:15:43 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:15:32 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:15:31 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:15:29 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:15:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:15:22 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:15:19 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:15:15 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:15:12 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:15:08 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/11/2023 09:30:20 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/24/2023 01:25:06 PM
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ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
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