RFL Rafael Holdings Inc - Ordinary Shares - Class B

$RFL my pity party is over. Long and strong. I ain’t ready to trade my shares for food stamps just yet! GLTA!! R_B

$RFL Prespecified analysis: Among patients receiving background miglustat and/or leucine therapy (n=78), Trappsol® Cyclo™ indicating slowing of disease progression by 71% compared with placebo at Week 96 (LS mean change from baseline of 0.46 vs 1.57 points; difference −1.11 points [95% CI −2.19, −0.02]; p=0.046).

$RFL leucine is a food supplement and cheap. Insurers will prefer Trappsol+leucine over mypliffa+miglustat. It's a slam dunk approval for FDA and EMA.

$RFL the NNPDF have spoken.. these people know their Sh1t when it comes to NPC more then us vagabonds ".We at NNPDF are excited and encouraged to share promising topline results from the Phase 3 TransportNPC™ study of Trappsol® Cyclo™ for Niemann-Pick Disease Type C (NPC). While the study did not reach statistical significance, in a prespecified analysis 83% of study participants showed a statistically significant 71% slowing of disease progression among patients receiving background therapy. We are also encouraged by important survival findings in infantile-onset NPC. An 85% reduction in the risk of mortality . An expanded analysis found a 94% reduction in the risk of mortality. given the unmet need for treatment options for children affected by NPC very early in life and further support NNPDF’s continued work to advance newborn screening for NPC. the opportunity for earlier identification, diagnosis, and intervention is critically important. "

$RFL a little side note with some info that i think is pertinent….. when i looked into the Wits university study using our drug (months ago) to remove the cholesterol in TNBC patients, what they found was that it worked accept for the fact that the body’s response was to start producing even more cholesterol. the sub group in our NPC study demonstrates that if you combine it with an up-stream inhibitor, it’s highly effective. this gives me some confidence that we will prevail.

$RFL it's bullish that holders of put options are covering instead of dumping their stock. We may yet have a merry Christmas and happy new year.

$RFL What's going on here? The data is very good. NDA in the fourth quarter. Conference call today at 8:30 add 2000 shares pm move long

$RFL A smidgeon of support from Jonas would help in the form of an at-the-market buy or the selling of a profitable subsidiary for non-dilutive cash. A rising price seems next to impossible with an equity raise looming. Perhaps Jonas likes issuing cheap and free shares at a low price to get even richer. Nice for him. Nice for Scott. Volume will only return if our CEO leads by example. But the peasants will smooch his butt on a falling price anyway. So, we dangle in the wind. Limply…

$RFL we are very fortunate that they had the foresight to include the sub group. it looks like it will be a painful wait for at least 6 months but at least hope is not lost. What seems clear is that cyclo works incredibly well in combination with other ”upstream” drugs and luckily most of the 94 patients were in that bracket.

$RFL Closure. Recalling the small group virtual chats with Scott and his excitement for this ‘asset’. There were signs at every corner, but I chose not to see them. Josh Fine with a $500K salary makes me sick.

$RFL It’s been a while. I probably lost 30k in this stock, back when it was Cyclo. Back then, it was fortune for me. As some of you may remember, I decided to cut my losses here a few years ago, based on the many red flags Cyclo was displaying. Constant delays on data, no partnership for either AD and TNBC, sketchy management, choppy market conditions, and, the nail in the coffin, a decisive detail for me: the fall of SEEL and Trehalose, a very similar sugar molecule to ours. I wish I had been wrong, for all of you that stuck around, but it is never a good sign when similar companies with similar molecules bite the dust. Many of us saw the potential, the mechanism of action made sense, but trials are there for a reason, and we can only guess based on how the company deals with it. Still, there will be volatility, and Jonas surely got a few tricks under their sleeve so this may briefly bounce. I ll keep watching. All the best to you guys, missing many of you.

$RFL I have been informed that the data results PR timeline has been extended to 2H26, so by Dec 31 at the latest. It is poor mgmt practice to announce timelines that you cannot meet, frustrating. They could have easily said 2H26 instead of 3Q.

$RFL Wednesday is the end of 3Q, top line results are expected to be announced this week...

$RFL Looks like someone SELLING ~2k of the Oct $5 puts at $3.20. Effectively buying the stock at $1.8.

$RFL This post lends credence to an approval pathway made available for Trappsol-Cyclo. Historically, the Phase/3 TransportNPC study was designed in response to the controversial clinical pathways of Sarepta’s eteplirsen (without a registration study) and Zevra’s arimoclomol (with a haphazard, cobbled together study). Both of those drugs were later approved — Sarepta’s after massive internal discord within the agency and arimoclomol while showing little evidence of a treatment effect as a solo agent. By contrast, TransportNPC was carefully designed in consultation with FDA to unearth these treatment effect relationships. A stat-sig result in an oncology study with thousands of available patients is difficult to achieve but a reasonable expectation. In a small study with diverse disease expressions and concomitant illness it’s nearly impossible. Consequently, anyone who suggests that the NDA once filed won’t be accepted is as much of a joker as SuperMWT has proved himself to be.

$RFL Deceptive leadership. Failed study. Mindless pumping on these very boards by folks who have run away or into silence. As I repeatedly stated, Trappsol would do about as well as its injectable cousin Adrabetadex ✔️ That there would be fewer severe SAE’s ✔️ That the effect as a solo agent or lack thereof would be similar ✔️ That a pathway to approval would remain viable despite these issues [no checkmark here until I see what Jonas has hidden from us in the study details]. The market is screaming “Not Approvable” in part because of the absolutely horrible track record of Cyclo-Therapeutics as an equity and Adrabetadex as a historical indicator. The folks who got it All Wrong are now off on the only tangential pathway of approval I claimed would be possible — revised ultra rare disease guidlines that emphasize drug to target engagement. I’d like to fool everybody by claiming I have a proprietary statistical formula hidden away on a secure hard drive but I have NOTHING for you.

$RFL Serious treatment-emergent adverse events were more frequent: 35.9% versus 16.7% with placebo.

$RFL can I say one thing I’m never selling my shirts thank you very much for your attention😎😎😎

$RFL I have been really busy but can some explain to me like a third grader what's happening here and how this will land. Been here a while and have a lot of shares. Appears to not be dead just yet. How's this play out?

$RFL started a position in $ZVRA which is as i understand it the only competitor to RFL in Niemann Pick, and ZVRA has the only approved drug for it. GLTALs!!