Asher77

[Asher77 @Asher3334]

@Elijahjstacy Yes, and that same logic applies to "you can't make healthy arms healthier". Trial design and SAP model decisions do not invalidate collected data. Absolutely nothing wrong with applying logic. Criminal not too.

[Asher77 @Asher3334]

@EOWheelsJ @US_FDA @SecKennedy @FDA_KyleD @CaseyMeansMD Data is clear that there is efficacy on the primary endpoint of the trial. The drug proved safe and there are no issues regarding US manufacturing. All agree that there are no alternative drugs for this deadly disease.
What happened to an FDA that promised adaptability?

[Asher77 @Asher3334]

@C5625797576187 The Trump administration has fought for logic in decision making yet old dogma still holds strong.

[Asher77 @Asher3334]

@Elijahjstacy Prayers are with you. Changing FDA guidance across administrations led to trial design flaws, boys without cardiomyopathy and those with PUL scores of 6 at entry. Participants who are not yet expressing disease progression alter significance. Subset data is amazing.

[Asher77 @Asher3334]

@MaryBschanck Appreciate you resharing my posts and cleaning up my grammar, carry on

[Asher77 @Asher3334]

@CountNefaria22 It is better for him in his current role but he is getting only 14pts without Tatum. With Tatum he drops one more space down the bench and that's a big move in relation to shot attempts.

[Asher77 @Asher3334]

@CountNefaria22 Simons is bad on defense and a poor passer. His offense is good and needed. Often in isolation unfortunately. This signals that Tatum will be returning and therefore the shots Simmons is taking will be transferred over, leaving less of a role.

[Asher77 @Asher3334]

@DrMakaryFDA Capricors Deramiocel data is remarkably positive yet will not be considered due to this CRL wording "These 50 secondary and exploratory endpoints were not prespecified for hypothesis testing.. As such, these analyses cannot provide evidence of effectiveness."
Wow, real flexible.

[Asher77 @Asher3334]

@leffler_aidan Dr Marty Makary is in position to help these boys with DMD. He promised to value real world evidence and embrace quality of life. Supported here by this moving patient testimonial.
This is a moment when a man's character is weighed, his legacy defined.
@DrMakaryFDA @FDA @US_FDA

[Asher77 @Asher3334]

@TheChiefNerd Capricor Therapeutics is working on such a vaccine with NIH.

[Asher77 @Asher3334]

@markland_55 @MartinShkreli @adamfeuerstein For those with the confidence that your best play in this market is to go against a blockbuster drug to help kids, I assume you did some deep research into method of action. Similar to my continued research over the last 5 years for which I have chosen to buy. Sleep well.

[Asher77 @Asher3334]

@markland_55 @MartinShkreli @adamfeuerstein Capricor now in active discussion with FDA to make LVEF the Hope-3 primary. Highly powered at N=52. Balls of steal to hold short over that definitive binary event that could drop at any time over the coming weeks.

[Asher77 @Asher3334]

@markland_55 @MartinShkreli @adamfeuerstein Blinded modeling looks strong for a comparable result to those seen in Hope-2, which showed remarkable and unprecedented efficacy for LVEF albeit a small sample size of N=12.

[Asher77 @Asher3334]

@markland_55 @MartinShkreli @adamfeuerstein With CMC and Safety now de risked Capricor has one binary event in front of them, the top line readout of the Hope-3 trial. In a matter of weeks we will see definitively how much of a sugar pill Deramiocel is. An expected billion dollar drug with a company trading at a 300M.

[Asher77 @Asher3334]

@adamfeuerstein An individual used race as a means to attack you. I am sure you don't believe that all the folks you have attacked by calling there support of a company trying to help dying boys, a "Cult", would condone that behavior.

[Asher77 @Asher3334]

@adamfeuerstein @davideyoungmd Hope-2 was a double blind placebo controlled trial, please stop with the misinformation

[Asher77 @Asher3334]

@kevinolearytv In the US, Capricor (CAPR) is the publicly traded leader in Exosome engineering. They have an Exosome based drug up for approval now (August Date) to treat Muscular Dystrophy.

[Asher77 @Asher3334]

@nealstweets CAPR

[Asher77 @Asher3334]

@realwillmeade Exosome delivery technology in BioTech sector