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I think we are missing the big picture here...that was a comprehensive investor-based update from IPCI. Either hell just froze over...or they are finally getting the point of being a listed company. If they can keep this up, it might end up being nearly as important as many of the potential catalysts contained within. Let's hope they keep this investor PR up.
My last post of the day (literally #15)... Regrettably, today made me lose faith in a management team who although I didn't always think was stellar- AT LEAST I had complete faith in them from an analytical/scientific perspective. That was swept away today. Sure we can blame it on people like Weezuhl, corruption of big pharma, the inability of the committee to see through a lot of BS and misdirection, etc.- but ultimately IPCI management completely failed to properly prepare themselves for the Rexista NDA submission and failed to follow the 2015 and newer guidance docs from the FDA.
I will ride out the initial tank, and hopefully hold shares long enough for our (possibly) upcoming profitability to kick in so that I don't lose a lot and hopefully another ANDA approval- but ultimately I feel I'll be closing out my almost 4-year position with IPCI as a loss. I'd love to stick around for further developments and PODRAS but at this point, my money is likely better invested elsewhere. Sorry Odidi- you (and therefore I) let down my family on this one. Thanks for to all here for the DD and good information you bring to the board.
Nope sad to say folks but as of right now...looks like Odidi and those responsible for the product development and associated studies have failed at their first attempt at Rexista. Perhaps this will turn around...but as of right now- we might be up for a rough several months stock wise.
"Dr. Johnson will you please finish up sir?" LOLOLOL. At least he honestly admitted a conflict of interest with competitors. AND then got kicked off the podium.
Agreed- all positive and supportive after that first speaker.
I dont think they are voters- but its nice to FINALLY hear the 2nd speaker who gets it.
I agree- that is downright rediculous. I mean c'mon... how far are you going to stretch stuff before you come to the realization that you have simple grasped for too many straws. For every 1 kid who apparently thinks a blue mouth, face, or nose is "cool" in this "rave" culture...it will save or deter 100 kids.
And Odidi just went on the record as saying FD&C 1 blue is not the same as Brilliant Blue...which from my understanding/research isn't the case. Not super confidence inspiring IMO. Hoping they pull this off still.
I believe it's #3 that is the big question mark at this point Doog.
and with Dr. Field's last two comments (or straight blows) to IPCI about the blue dye... I'd say more like 40% yes / 60% no.
Still tough to say IMO. Depends if the committee members feel the proven benefits of approving Rexista outweigh the unproven possible negatives. I'd still say 50/50 at this point.
Agreed- Dr. "Cohen" is doing them no favors with his answering. Odidi would likely be better off fielding the questions himself and benching Cohen.
Thought the same myself. Seems like they could have been better prepared in some regards. Overall sounding okay- but... a few questions / further data would have been helpful.
Thanks for the updates Fred- keep em' coming!
Right there with you on all accounts Mad! If Odidi is anything- it's a great scientist. Let's hope we placed the right bets. GLTYA
Good luck tomorrow everyone! Exciting times for IPCI.
Oh and nutshell explanation from a non-chemist:
A chemistry based approach to regulate the release of active drug ingredients via variable and controllable layers of drug coating:
[0022] According to an aspect, there is provided a unit dose formulation comprising at least one active substance, wherein release of said at least one active substance is inhibited when the number of unit dosage forms ingested exceeds a predetermined number.
[0023] In an aspect, the unit dose formulation further comprises at least one actuator and at least one regulator, whereby when the unit dose formulation is exposed to a fluid media having a process variable, and a predetermined threshold is established for the process variable, said at least one regulator is capable of adjusting the variable to control the release of said at least one active substance via said at least one actuator.
Read more: http://www.patentsencyclopedia.com/app/20160022590#ixzz4nsColr6V
PODRAS was developed (and the necessary patents issued) too late for inclusion with the original Rexista formulation. Therefore, from my understanding, they plan to utilize funding obtained from Rexista (partnership, etc.) to drive studies to prove PODRAS as safe and effective as advertised, and will then look to incorporate it into future formulations of drugs such as a new Rexista (there was a name posted for this but can't recall), Regabatin, AND possibly license the technology out to other manufacturers for their drugs which are subject to potential overdose. If proven as concept...it could truly be huge- esp if it becomes required for at-risk medications.
Thanks for the personal opinions and interpretation Samsa. Very much appreciated!
Samsa- what do you think "The parties’ competing proposals are set forth in the proposed Scheduling Order." is referring to? Specifically the usage of the word "competing"? I know this is pure speculation- but wondering if this is typical legal usage, or implying a competition between Grunenthal vs Purdue?
Right on Fred. I agree completely- I fully expect the AdComm outcome to be closely associated with the terms and choosing of a final partner for Rexista. Very interested to see how this plays out. Would live to see Purdue come full circle and partner on Rexista. Time will tell!
From the guidance docs: https://www.fda.gov/downloads/drugs/guidances/ucm198650.pdf
Question 3: Should a human abuse potential (HAP) study be conducted?
A HAP study (also known as a human abuse liability (HAL) study) assesses abuse potential in
individuals with a history of recreational use of drugs of abuse. In determining whether a HAP
study should be conducted, it is important to assess whether there is evidence that the new drug
produces any of the following:
• Responses in animals in general behavioral studies that are similar to responses to known
drugs of abuse
• Generalization (similar effects) to a known drug of abuse in animal drug discrimination
studies
• Rewarding properties that support animal self-administration or conditioned place
preference
• A profile of abuse-related AEs (including euphoria-related AEs) in clinical studies in
healthy individuals (phase 1) and in individuals with the disease of study (phase 2/3)
These studies are discussed in detail in Sections IV and V. If evaluation of the data from these
animal and human studies identifies abuse-related signals, it is likely a HAP study will be
necessary to conduct. Detailed descriptions and considerations in designing a HAP study are
discussed in Section V.C.
If an evaluation of data from animal and human studies does not show evidence of abuse-related
signals, a HAP study is not likely to be recommended. However, the sponsor should discuss
available data with the Agency to confirm whether or not a HAP study should be conducted.
Once the data from all appropriate abuse-related studies in animals and humans are evaluated,
final decisions can be made regarding the fourth key question:
Contains Nonbinding Recommendations
Question 4: Do the animal and human abuse-related data show that the drug has abuse
potential, and will it therefore be subject to control under the CSA?
The abuse potential assessment submitted by the applicant in the NDA should include full
protocols and primary data, as well as a statistical analysis of the data. The assessment should
also include a discussion regarding whether the data show that the drug has abuse potential,
proposed labeling for the DRUG ABUSE AND DEPENDENCE section and other relevant
sections, and a proposal for scheduling under the CSA, if appropriate (see Section III.E).
Following the CSS review of the information submitted in the NDA, CSS determines whether
the drug has abuse potential, suggests appropriate labeling, and drafts a CSA scheduling
recommendation.
My thoughts: Odidi is not new to this- I'd be willing to bet he has had all of the appropriate talks with the FDA to arrive at the conclusion that HAL studies are not necessary given the results of their other data / studies. Just my .02.
I think this is what they are referring to:
Summary of Clinical Data for Oxycodone Extended-Release Tablets
The proposed indication for oxycodone extended-release (ER) tablets is for the management of
moderate-to-severe pain when a continuous, around-the-clock analgesic is needed for an
extended period of time. The safety and efficacy of oxycodone ER tablets is based on the
demonstration of bioequivalence to the listed drug, OxyContin (NDA 22272) for this 505(b)(2)
New Drug Application. The clinical program for oxycodone ER tablets consisted of seven Phase
1 pharmacokinetic (PK) studies using the final to-be-marketed formulation. Efficacy studies
were not required for this NDA application if bioequivalence with OxyContin was established.
The safety information collected in the pharmacokinetic studies was of limited value due to the
fact that these were generally single-dose studies (except one multiple dose study) conducted in
healthy volunteers who were naltrexone-blocked. There were no human abuse liability studies
submitted with the NDA. No new safety signals were identified during the review of the
oxycodone ER tablets application beyond what is already known for oxycodone products.
In a preliminary review posted ahead of a meeting of independent advisers on Wednesday, FDA scientists said that abuse-liability data had not been submitted as part of Rexista's marketing application
What are they referring to here? I was under the impression that the abuse liability data had been submitted.
Looks pretty awesome to me! Thanks for sharing cysonic!
https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM568075.pdf
Have a good weekend all. We gear up next week for the biggest potential week thus far in IPCI history. Good or bad here we go (I'm guessing good- but that's my opinion). Waiting around here for almost 4 years for this. See everyone next week!
Thanks for the clarification Samsa. I wouldn't be the least bit surprised to see partnership news /developments after Rexista before the PDUFA date personally. I could easily see a to-be partner wanting the confirmation/support (or potential lack thereof) from Adcomm before inking a deal of this size. Just my .02
I'll give IPCI credit for one thing...they sure know how to advertise an offering... Jeesh... lets stop with the bad PR and move into the AdComm / additional ANDA approvals already lol.
GM and happy Monday Doog and all. Nice accumulation going on this AM. Hoping to see this continue (for the most part) into AdComm!
As of July 11, 2017, our cash balance was $0.6 million. We currently expect to satisfy our operating cash requirements until September 2017 from cash on hand and quarterly profit share payments from Par and Mallinckrodt. Should our marketing and distribution partner, Mallinckrodt, soon be successful in fully commercializing our generic Seroquel XR® (all strengths of which were launched in June 2017), then we may be cash flow positive in the second half of 2017. Failing this, the Company may need to obtain additional funding prior to that time as we further the development of our product candidates and if we accelerate our product commercialization activities. There can be no assurance as to when or if Par will launch the remaining two strengths of its generic Focalin XR® and, if launched, whether they will be successfully commercialized, or if generic Seroquel XR® will be successfully commercialized. If necessary, we expect to utilize our at-the-market offering program to bridge any funding shortfall in the second half of 2017.
Great earnings- I've said it for a long time...you can only hold down a speculative stock for so long. Once it becomes productive vs speculative it will transfer into a growth based valuation approach. I believe we are seeing the beginning of this transformation.
https://seekingalpha.com/news/3278061-intellipharmaceutics-misses-0_01-beats-revenue#email_link
Can't wait until next Q!
Solid day!
Done! Now, will it hold?
Right on Doog!
I arrived at largely the same conclusions that you did Fred. Personally I feel the author is unfairly and disparagingly biased against IPCI and the his "reasoning" leaves much to be desired. Later he goes on to state he doesn't trust the company because it is a husband and wife operation- given his largely logical approach to the rest of his analysis this seems out of character and unfair to IPCI given what they have going for them. In addition, IPCI's technology has yet to fail them in any endeavor- you can't say the same thing about their competitors. I feel the author had financial reasons to avoid mentioning IPCI and shouldn't be considered a good source of information. Just my .02
Agreed Wim!