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$CAPR going to post some dd here if it helps out any of longs here (if anyone here is still left in the stock that is)
$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.
This board died looks like? People got shaken out of their shares?
Quite possible to see it tomorrow. I’d like it for sure.
Great ready mofos. Co just hired Wxec Director of Kite as their VP of Quality. New VP obviously saw something in roadmap that made her make the switch from Gilead. Moon coming imo $CAPR
Yes I did. They’re executing everything they said they would
No chance. Did you see the kids video tonight? $100 pps coming soon imo $CAPR
I’ll be tuning in tonight. In May we were told co cannot speak much on the data due to embargo. Now they apparently can. So fda has pored thru it and have made some decision on bla?
Excellent. Glty
Cool georgie.
Did you follow your own call and you bought at $4.07 and you held your pincher all the way to low $3s
Asking since you’re partying tonight. Must be a nice trade for you ha
Dude what garbage you post on this iHub boards.
New tute in $CAPR w/ 1.2M bet https://fintel.io/so/us/capr/trellus-management-company-llc
I’m a big Seinfeld fan. It was one of the most brilliantly done shows ever.
Regulatory Developments
In June 2017, we had a meeting with the FDA to discuss potential clinical endpoints that could be used for registration strategies for CAP-1002 in the DMD indication. The minutes of the meeting indicated the FDA's willingness to accept Capricor's proposal to use the PUL test as the basis for the primary efficacy endpoint for clinical studies in support of a BLA. The PUL test is an outcome instrument that was specifically designed to assess upper limb function in ambulant and non-ambulant patients with DMD.
In December 2018, we met with the FDA as part of the expedited review afforded under the RMAT designation. The agency stated that the trial would need to provide evidence of clinically meaningful changes in the PUL, as well as other evidence supportive of CAP-1002 efficacy for patients with advanced Duchenne muscular dystrophy, in order to potentially serve as a registration trial.
7
In October 2019, we had a meeting with the FDA to discuss, among other things, the results of the 6-month interim analysis of the HOPE-2 trial and our path forward with our DMD program. During the meeting, we proposed the possibility of accelerated approval. The FDA was not supportive of an accelerated approval pathway at that time and noted that the HOPE-2 trial was designed as an exploratory trial and that the 6-month data from the HOPE-2 trial did not provide substantial evidence of effectiveness to support a future BLA. The FDA did, however, indicate its support for conducting a Phase III trial of CAP-1002 for the treatment of DMD. In addition, the FDA reiterated that as part of our RMAT designation, they are willing to work with us to further the clinical development of the therapy.
In a follow-up to the October 2019 meeting, Capricor requested an additional meeting to clarify endpoints for future clinical trials. In a written response, FDA supported the use of the full PUL 2.0 from baseline to twelve months as a primary efficacy endpoint as long as clinical meaningfulness can be demonstrated. They suggested that a 1.0 point difference appears suitable to demonstrate product efficacy to support a BLA.
In a Type B meeting with the FDA in 2020, we focused on the 12-month results from the HOPE-2 trial and discussed next steps and a pathway to approval of a BLA for CAP-1002 in DMD. The FDA has continued to encourage us to conduct a Phase III study; at this time, however, we are still discussing the pathway forward for this program with the FDA and have not initiated a Phase III study.
https://www.sec.gov/ix?doc=/Archives/edgar/data/1133869/000110465921036410/tm211144d1_10k.htm
As info - $CAPR got 2.4 PUL score from HOPE 2 study.
If you don’t have anything, ok to post nothing?
He is a mod that posts random junk here.
Why bud missed?
Agree with you XW...
They’ve a lot going on. I think we will see this co will trade north of $25-$40 by end of Q3.
Linda has killed the stock (again).
Dip buy time TOMORROW imo $CAPR
Sorry but not interested in crypto
Finger crossed.
Also saw some chat room alerted yesterday I think so who know if those sheep were buying. Man I really want to become a furu and run a chat room for sheep
I think news Monday señor. Always was expecting a Big Bang before earnings and today’s ah price action only solidifies that hypothesis for me.
Lmfao.
Yeah no fun. Ah was different picture though
$CAPR re watched this stellar presentation to ppmd from June 2020 to remind me what exactly am I holding here for dmd indication. Lot of progress has happened since then e.g.
- OLE trial underway
- Lonza contract
- Covid therapeutic trial underway at 4 centers
- Sarepta trial failure if I may add
Thanks for taking one for the team. I think you made a mistake but glty
Capr just weak with no interest from buyers. Linda won’t Pr even if her life depended on it to address mkt interest.
Yes I did. Happy to see it getting some eyeballs $CAPR
Nice. Me too. This will turn a lot of heads one day. I’m sure about it personally $CAPR
Nice couple of us still here. Larry must be getting on phone with Linda in 1...2...3 $CAPR
Anyone left here or all flushed out? $CAPR
Open the markets!
Lol. I do hope as well they hire another C level exec soon. Linda and AJ look stretched. They’re very stingy I’ve felt and need to open up their wallets a bit more now that they’re not trading at $4M mkt cap lol. Every qtr they use like 2M of their atm to barely cover their op ex.
You touched upon few topics in your post but 100% agree with all of them. This stock literally has an absurd risk/reward ratio and I cannot shake that feeling. Have literally looked under every rock. If just one of those 3-4 value drivers pans out, generational wealth will be built by longs. I can see a day in next 2-4 months when this trades like a $VERI or $DMTK. Different industries etc but similar floats and mkt caps.
Larry’s 2M share buy has been a good confirmation for me personally. He sucked out 2M out of already small float. When this one comes under buying pressure, watching the tape will be sight to behold imo.
And yes, linebacker is my favorite poster ever on any board. I told him do as well lol. $CAPR
Either of this value drivers hits, we land on the moon as first stop no kidding
Watch for vaccine progress next week or first half of March. My best guess.
Er mar 16-18 sometime imo $CAPR
I agree with you. Hope it’s coming our way $CAPR
See feb 21 agenda $CAPR
http://conferenza.parentproject.it/#21-Feb-2021