wimuskyfisherman
5 years ago
Fabius- I think the class action suit should go after IPCI's only asset. The approved ANDAs and pending ANDAs. The reason I say this is in bankruptcy IPCI has two major debts:
1. Odidi Loans
2. Class action suit that was recently settled but still pending approval. In all likelihood insurance covers most of this, but some of it could fall onto IPCI.
IPCI has no money, no real estate or anything of value. They have some used lab and manufacturing equipment but that is not worth much. Thus, I say go after the ANDAs. Why? They are the only thing of worth. Also to prevent Odidi from running off to China and being able to manufacture and profit all by himself.
When you think about it, it does sound like a scheme. He funded ANDA approvals through a pump and dump scheme with the likes of Wainwright, etc. He never commercialized them and made them appear worthless. He never bought a single share of IPCI with actual money. But he loaned the company money at 12% interest. This guy is no fool. He knows that all debt gets 100% paid out before a single penny of equity in bankruptcy. So the debtors will take all IPCI assets... So that pretty much leaves Odidi with whatever he wants.
fabius
5 years ago
I will keep on following the news to see if I can join some kind of class action (although I am in Europe).
as I wrote on this board the day before AdComm, even for me that I am surely not used to read clinical trial analysis or other drug related stuff, it was clear that IPCI was far away from getting an approval.
Now I wonder: can we consider Odidiot just an idiot ?
surely not; he is a con man, who likely understood some years ago which was the way to raise money and "survive" (with very good salaries for himself and family & friends) without having a remote possibility of getting a revenue generating product on the market.
Look at the shelved ANDAs, at the Regabatin stall, at the several CRLs he has been receiving during all these years (= incompetence).
He knew he was going to fail (otherwise you don't file incomplete studies and get multiple CRLs on almost all your applications).
He is a f...g liar, sleeping with the devil
AnAnon123
5 years ago
wimuskyfisherman - It's not at all comparable to OxyContin (which is a low benchmark for ADFs). Axiris XR is laughably bad, worse than any other ADF currently on the market. The intranasal Cmax (amount of drug in your blood) is almost DOUBLE that of OxyContin. As for IV and extraction, all Intellipharmaceutics has is gelling. It's easy to crush, makes statistically smaller particles than OxyContin, and fully extracts in alcohol. Intellipharmaceutics can try to hide the data with liking studies, but the numbers are awful.
AnAnon123
5 years ago
Intellipharmaceutics will ultimately get a CRL, with the AdComm ending with a mixed to solid No vote. The first time around, it was clear there was no chance of approval. Relevant HAP studies were missing, data was poor, and making claims using the dye guaranteed there would be no approval. However, after reformulating and conducting additional studies, Intellipharmaceutics was given a huge opportunity for a positive outcome. FDA mostly wants ADF applicants to follow their guidance and conduct the necessary studies; check the right boxes and you get approval with labeling. Today's meeting was an especially good opportunity given recent events at FDA. There hasn't been a meeting of the Analgesic committee in a while, and several key members of CDER involved in the first CRL are no longer with FDA.
Just by looking at the background documents, you can tell Intellipharmaceutics blew it. Study data is again poor and incomplete. Stemming from what looks like attempts to save money, the little that was done is clearly below expected quality and rigor in the CII industry. On top of that, yesterday's meeting set the tone for the new committee. For those who didn't see the results, the meeting ended with an extremely harsh 27-0 No vote. It's clear the FDA and this AdComm have an eye toward the epidemic, and Intellipharmaceutics needed a strong backgrounder to overcome this concern. I predict Esteve, the applicant in the current AM session, will receive a solid Yes vote. This will lend the committee some credibility as opposed to blocking every applicant currently under review. Then Intellipharmaceutics will comfortably be given a No vote in the afternoon.
WeeZuhl
5 years ago
It will all come down to the chewing and snorting HAL studies.
Ouch. Not only is it a total failure in both oral and intranasal drug liking studies, but snorting IPCI's formulation actually results in SUBSTANTIALLY higher blood concentrations of oxycodone when compared with snorted OxyContin and snorted OxyIR. Ruh-roh, Elmo.
https://www.fda.gov/media/134150/download
• The ground IPC oxycodone ER tablets were associated with 67% higher Cmax, 122%
and 97% higher partial AUCs (AUC0-1h and AUC0-2h, respectively), 26% higher AUCinf,
and 1.5 h earlier median Tmax compared to crushed oxycodone IR tablets.
• The ground IPC oxycodone ER tablets were associated with 64% higher Cmax, 78%
and 63% higher partial AUCs (AUC0-1h and AUC0-2h, respectively) and 0.5 h earlier
median Tmax compared to ground OxyContin tablets.
The mean drug liking for snorting and chewing is actually HIGHER for IPCI OxyEr than for either OxyContin or OxyIR.