Member Info for Alquemie

What happened to my ***ing capitals?- Oh we, the gist should be clear...

"pharma experts"?- that horse has long since bolted. i could detail the endless list of risible operational and deal-making errors, or relate the vitriol-laced, but largely accurate, opinion of one past major investor, but that would only be restating the blindly obvious.

rpg has no input or influence on the china approval process, although i strongly suspect that historical idiocy, specifically lack of understanding of cmc issues may have fatally compromised this. now, fortacin was never going to be more than a low earner in europe, but even this few millions of euros potential was irrefutably hamstrung by the same cmc fiasco and in giving recordati complete and sole control over marketing strategy.

the failure to make any progress in the us results screams of arrogance and ignorance, specifically over regulatory strategy, but also zero understanding of how the us pharma market works. admittedly, it takes some sort of warped genius to make a high regulatory hurdle even higher through the cack-handed design and execution of a pilot clinical study and then ****ing off the fda with fatuous spa requests.

"pharma experts"?- a combination of thunderbirds, the fantastic four and the avengers working overtime couldn't rescue this.

Big "thank you" for the weekend posts which have brightened up a dull Monday- Bothwell's registrational study "design", US licencees, and still no realization that the US patents expired 12 years ago.....comedy gold!

Only a single NMPA approval sent out today (long list last week). Squeaky bum noises growing ever louder?

Ah, the voices are back again, although either mumbling heavily or speaking in tongues...

Or are you dabbling with CrapGPT again, Bothwell?

"Baron!- Angry villagers with torches and pitchforks!"

Let me see now...ah, yes- Phase II data reported over four years ago which failed to validate a putative co-primary endpoint or even show a meaningful treatment effect. SPA request kicked out by the FDA (twice!) due to lack of treatment effect and dodgy statistical analysis, with proposed endpoint kicked into the long grass.

While the continued blind belief is funny in a WTF sort of way, perhaps time for LTHs make their way back to reality? After one last chorus of "I still believe in the product", of course...

But there's always China, well perhaps...certainly no good news winging it's way to RPG from today's NMPA list of 175 approvals. Congratulations due to Harbin Pharmaceutical Group for "Fat Child Powder" and Jilin Deshang Pharmaceutical for "Deer Placenta Cream". No home should be without them.

Likely not surprising, but Senstend not included among the 75 approval letters issued by the NMPA today (31st December), although congratulations to Fusong County Traditional Chinese Medicine Co on the success of "Wind-dispelling medicinal wine" among their many other approvals.

On the other hand, not aware of bad news among the many rejection notifications sent out in December. NMPA does appear to be going through another hardening of stance, although so far largely directed at domestic generics producers.

Keep watching for a Heads-Up in the New Year...

Easy there, Dougie- it's not as though nothing has happened. Old Mellers has a second children's book out "Juno Goes To London", a follow-up to "Juno's Ark"- Five stars on Amazon! Apparently inspired by "Jim’s six rescue Podencos, a breed of Spanish hunting dog, historically loved for its playful, intelligent nature but too often abused and abandoned".

"Abused and abandoned, eh? Just like RPG shareholders, then...

Well...not impossible, but be mindful of the red flags, specifically CMC issues. Clinical trial material manufacture and specification differed from later commercial supply, and recent API supply issues could have consequences- an alternative API supplier would mean DMF resubmission, and hiatus in manufacture might postpone the mandatory NMPM site visit. I'm aware of HFA 134a supply issues, something that's only going to get worse as the low-GWP propellent switch picks up momentum.

Not necessarily showstoppers, but could add months to a decision.

Mentioned before, but given the pressure on Chinese investigators to publish, and that results from the two initial PK/tox studies made it into print very soon after completion, I do wonder about the conspicuous absence of pivotal study data- a repeat of the 50% placebo effect that scuppered the US Phase II, or simply keeping the known generic competitors guessing?

I'll go with my coin toss prediction made many months back.

Nothing wrong with your search skills, essentially out of stock in all territories. Supply has always been at very low level, and low demand means no distributor incentive to build stock. I suspect the underlying reason is the shortage of lidocaine as an API, which is affecting availability of other lidocaine-containing products. Less likely reasons are continued formulation issues or perhaps Genetics new owners have deprioritized supply in favour of respiratory pDMIs before their existing high-GWP products are removed from the market.

"Gaslighting" (ga·slai·tuhng)- the practice of psychologically manipulating someone into questioning their own sanity, memory, or powers of reasoning.

ICD-10 F22

Bothwell, flattered that you've reposted my dismantling of RPG's nonsensical posturing. Just a suggestion, but why not salve your evident angst by asking the FDA for clarification? After all, they were the ones who had the temerity to actually be guided by the study data, leading to a questioning of evidence for treatment effect and of the statistical analysis, then turfing out two SPA requests, with dismissal of the PEBQ as an endpoint.

But, hey...what do they know about the approval process, eh?

And, returning to a previous suggestion, why not look at the clinical study data? It doesn't need big brain statistical expertise to reveal the absence of meaningful therapeutic effect, just simple comparison of means between treatment and placebo groups. Just think- peace of is mind only five minutes and a calculator away.

That's 2024 AR.

Bless...did you miss this guff when it appeared near verbatim in the 2004 AR?

Most CROs offer basic no-commitment protocols, probably in this case just for schitz and giggles since RPG can't cover the cost of investigator coffee and doughnuts. Lemme see now- a Phase II which failed to show a significant treatment effect; no validated acceptable co-primary endpoint; kicked into the long grass by the FDA three times (2010ish EOP2/pre-NDA submission, two SPA knockbacks), oh, and the unresolved fixed-dose combination issue. Belly laughs all round!

Oooh...the cheeky scamps. As much as I enjoy RPG's madcap antics, they are not the sort of of client we have ever, or would ever, take on- we don't represent comedy acts.

Dumped my last handful of PLE toilet tissue many years ago. It's worth remembering that the end of the Universe is only 33 billion years away, so not enough time left for US approval.

Glad to hear it- just don't go taking any cheques.

Damn. Bothwell...looks like RPG commissioned you to draft the front end of the 2025 interim report- good job!

Or are you are off the meds again?

The die was cast long before 2014, when, unfathomably, PLE and their then US partner Sciele pushed on with what were intended to be pivotal studies without nailing down the FDA stance on acceptable endpoints. And, as history tells us, any chance of developing a validated endpoint was scuppered by RPG penny-pinching and the ludicrous belief (or deliberate misdirection?) that an underpowered pilot study would be sufficient to satisfy the FDA. Hilarious that the gaslighting continues. Perhaps it's pathological- corporate delusional disorder?

RPG claims to have canvassed "reputable" CROs (as opposed to disreputable CROs) with respect to Phase III design. The appalling Phase II results, which inevitably produced repeated SPA denials, nailed the coffin shut, although thorough cremation might be a more accurate metaphor. Any continuing guff about US approval is a blind to maintain the illusion of value in Fortacin.

True, absence of an FDA acceptable co-primary endpoint does not, per se, prevent the undertaking a Phase III study. This would necessarily be a two-parter (endpoint validation alongside efficacy and safety: a historical design suggests recruitment of around 600 couples). Approval would hang on an AdCom decision. So, only shortage of cash and a 100% probability of failure holding this back...

As to licensing, RPG's "ownership" comprises a nearly 20 year-old IND, oh and the stunning "Senstend" trademark (US patents expired over a decade ago). Workable deal structure aside, who do you believe is dumb enough to pony up the cost of taking an ancient, mediocre knob spray with a ten year history of commercial failure into the US market?

Of course...how silly off me. The clear field explains the global market dominance of Fortacin...