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 Okay gang. So what we were waiting on happened. Now, 60 days or less til.we have an answer. Just an fyi , bulls will not have much to say over this time period. Bulls will patiently wait, as they know that the ingredients have all been mixed, prepped, and put in the oven. Now just waiting >61 days til we see if its a 4 star meal or a spam and jelly sandwich. The team at $RFL seem to think it will be 4 stars.

$RFL reasons why we're PRV eligible and applicable for all patients including infants even if Beren is approved on November 17

$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 Regarding the potential approval of Adrabetadex (the injectable Cyclodextrine) I’m not certain as to whether or not that would disqualify Rafael from receiving a Priority Review Voucher if both drugs travel over the finish line. If anyone has evidence that it still would be possible, please post it as I thought that the decision was based not only on rare disease approval but on a unique mechanism of action as well. Unique delivery would likely not qualify. Steadfastly

$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 "With the data in the NDA and Orphan Drug, Fast Track and Rare Pediatric Disease designations in place, upon the FDA's filing of the NDA, we believe remibetadex is well positioned for review, and an approval would make it eligible for a Priority Review Voucher, a potential source of non-dilutive capital. With this important milestone completed, we are preparing for a potential commercial launch, and we look forward to working with the FDA as the regulatory review process advances. We are grateful to the investigators, patients, families and advocates who made this milestone possible."

$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 Immanent Failure? Money and Hope are running out. This Could be the End folks. This was a big week for RFL. On October 28, Cyclo Therapeutics submitted a New Drug Application to the FDA for remibetadex to treat Niemann-Pick Disease Type C. The catch is that the trial did not meet its primary endpoint in the overall population, though a prespecified subgroup on background therapy showed significant benefit. The NDA requests a pediatric priority review voucher. Full-year results were also released: the net loss narrowed to $29.6M from $30.5M. Two things to keep an eye on: cash fell to $22.1M from $52.8M a year earlier, and management reports substantial doubt about continuing as a going concern. The next catalyst is whether the FDA accepts the application for filing.

$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 readout did not disclose anything about cognition benefits. Any demonstrated benefit in cognition will lock EMA approval. EMA rejected Mypliffa for not showing any benefits to cognitive decline. We know Trappsol does so well that it's being trialed for AD.

$RFL the RFL team does not think it’s 4 stars. They are just trying to prove they have created something edible. Trappsol is like the subway buns with yoga mat material in them. Now they are tasked with convincing the FDA that it should be considered food.

$RFL something about reverse parking a jagx around these numbers Who knows if it plays out. Would be a wild ride if so

$RFL what's going on brehhh? I can't buy to close my 10/9 2.50 naked covered calls that I super banked on.

$RFL Why the subgroup is weaker evidence than it sounds This is the part that gets glossed over in the headlines, and it's the thing I'd want you to sit with. The subgroup is 83% of the trial. If 78 of 94 patients clear significance at p=0.046 but all 94 miss at p=0.19, the 16 patients not on background therapy either did meaningfully worse or added enough noise to swamp the result. A subgroup that comprises most of the study and outperforms the whole study is a sign of fragility, not robustness — it means the finding is sensitive to exactly which patients you count. And p=0.046 is sitting on the line; it does not survive multiplicity adjustment under most frameworks, which is precisely what FDA statisticians will apply.

$RFL The honest counterweight: the effect sizes are consistent in direction and magnitude (64% versus 71%), which is more reassuring than a subgroup that appears from nowhere. NPC is ultra-rare, fatal, and pediatric, and the agency has shown real flexibility in that setting. Trappsol carries Fast Track, Orphan Drug in the US and EU, and Rare Pediatric Disease designation that could qualify for a Priority Review Voucher — a genuinely valuable asset if approval comes. The pre-NDA meeting does not mean what the press release implies "Based upon its previously announced pre-NDA meeting, the Company remains on track to submit the NDA in the fourth quarter" is carefully worded. That meeting happened before anyone had seen the unblinded data. FDA agreeing on the shape of a submission is not FDA blessing the evidence inside it. Filing is a company decision; acceptance and approval are not. Read that sentence as a commitment to submit, nothing more.

$RFL I decided to sell half of the entire position. I bought $VTVT instead, with strong potential for a large profit. read all my post about $VTVT