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Any Prediction of results due first half of September or second half?
My understanding of timeline to report results
Last patient April
10 day follow up so let's say finish May for follow ups
June lock database
July start analysis
Aug focus adverse events / safety metrics
Results Sept. X?
Conference call - did anyone understand the IP question?
It sounded like they rely on two patents they don't own?
One expires in April 2018 and the other in 2020.
So they are reliant on getting a new license?
Two Issues, Two perspectives to consider the data in context
Excluding overdose deaths, there were 20 (0.21%) deaths in subjects who received HEPLISAV-B and 7 (0.18%) in subjects who received Engerix-B. ...percentage wise fairly balanced and no time correlation to vaccination
Using population-based databases in HBV-23, in the HEPLISAV-B group, age-, sex-, and race- adjusted incidence rates of observed composite MACE outcomes and cardiovascular deaths were lower than expected, and myocardial infarction and strokes were similar to expected. In the Engerix-B group, observed composite MACE outcomes, deaths, myocardial infarctions, and strokes were each lower than expected. Notably, in HBV-23, the observed rate of myocardial infarction in the Engerix-B group was 6.8-fold lower than expected.
Expecting =>2/3 votes yes for safety
I think we will gEt zalviso results before we have to worry about that. Any thoughts on endpoints?
Primary Outcome Measures:
Device Functionality: Proportion of patients who experience at least one system-generated error [ Time Frame: Up to 72 hours ]???this will be determine from investigator notes?
How is this different than the below endpoint? Other than your using device logs...
Proportion of patients who experience at least one system-generated error based on the Controller data while using the Zalviso System ???this will be measured by the device and needs to be less than %5?
Device Usability: Proportion of patients with misplaced tablets [ Time Frame: Up to 72 hours ]
Proportion of patients with misplaced tablets
??this needs to be less than 5%
Would have been nice to list the quantitative values we need to meet.
I hope this company isnt the next EGLT
Are we sure no dilution the next three months?
yes any day
i was predicting july 18-20th.
july 6th will be 30 days since trial has been completed going by PR date when trial fully enrolled plus 8 weeks.
the p3 data took 51 days after last patient treated before PR of results,
P2 is less data so 51 days from june 6 or may 31st if you believe fdaclinical trial site completion date as the worst case date for PR
1 reason one...it will be a success is this a p2 trial and its usually better controlled, patients tightly screened, we have a history of this drugs performance and it has a good safety profile
#2 they are not testing against a placebo but greater decrease of IOP in the combo drug vs single arms
#3 we don't have to rely on hope ....just consistency of the drug's lowering capability in previous p2 similar combo trial 2014 showed mean reductions see 10k filing;
After eight weeks of BID dosing in Part 1, patients treated with trabodenoson co- administered with latanoprost experienced further mean reductions of IOP of 3.4 and 4.9 mmHg from diurnal and study baselines, respectively, beyond the IOP-lowering of latanoprost. After switching to QD trabodenoson in Part 2, and treating for an additional four weeks, QD dosing with trabodenoson resulted in a mean reduction in IOP of 4.3 and 5.8 mmHg from diurnal and study baseline, respectively, from the IOP on latanoprost alone. At the end of Part 2 (after 12 weeks), the IOP-lowering seen in the Study Eye (the eye treated with trabodenoson) was statistically significantly greater than the IOP drop of the patient's Control Eye (the patient's other eye that only received QD latanoprost).
How often do you have a sneak peak of a p2 and results of p3 showing a drug is active.
I believe they might have just tested the 3% dose not 6% in the previous p2 combo trail but I need to check on that.
#4. the Phase 3 trial of trabodenoson was effective in lowering IOP, even though the trial failed. The Placebo was the issue. Combo trial is a different design vs monotherapy trial.
#5 I believe we are not reporting various data times as Endpoints such as 8am and 4pm times.
Just one "mean IOP change" from diurnal baseline for each dose arm of the trial.
#6 it's a p2 study it's not powered to show statistical significance ...so you don't have to worry about getting a p value of 0.055 and just miss out
The only CON I can think of is a 3 month study duration might have been better than 8weeks.
May 10th PR top of line data in July
PR April 11 completes recruitment
8 weeks of treatment puts us at June 6 assuming following placebo run in completed which seems right since ( FDA clinical trial site has trial completed at end of May )
2 weeks to QA and lock database
June 20th statistical analysis starts
July 18th prediction results presented to company , if I am off a week then July 25th.
Anyways the later half of July be sure to check for possible PRs at 7am, 8:15am and 4:15pm
I meant comparison test to Oxycontin OP. My edit time expired....
Seems like we are reasonably in the clear until it's out there a few years and can be reassessed.
I would expect word of an ad com date very soon if the FDA intends to meet its timeline.
Do we have any similarities with Opana? Are product is difficult to inject so are we in the clear?
The company did an abuse deterrent non inferiority study so we are as good as oxycodone.
http://www.npr.org/sections/health-shots/2016/04/01/472538272/how-a-painkiller-designed-to-deter-abuse-helped-spark-an-hiv-outbreak
http://secure.medicalletter.org/w1476a
does this mean all dosages for Focalin are for sale?
.....launches of 4 additional strengths of generic Focalin XR® by
last PR had two dosages left....
can you check what the new court docket entry is about?
Thanks!
do we know what related companies IPCI`s law firm has represented related to fighting purdue patents claims?
did they represent COLL?
unfortunately,
Mallenckrodt hasnt updated their product catalog which leads me to think they needed a couple of weeks from approval to launching this product.
Purdue Litigation Campaign
Patent |#Patent Litigations | Status|Purdue Pharma Defendant Parents|Cases
8309060 | 18 | Open | 32 | 107
9060976 | 5 | Open | 32 | 107
9073933 | 9 | Open | 32 | 107
9492389 | 2 | Open | 32 | 107
9492391 | 2 | Open | 32 | 107
9522919 | 4 | Open | 32 | 107
Two out of six patents have been in several litigations cases. I was most worried about the older ones but they have been involved in 5 to 19 litigation cases apparently.
in reference to the following; Purdue should be "estopped" (meaning barred) from being able to enforce the patents as outlined in law when issues of patent invalidity are raised
not all patents have a judgement against them as invalid...so this could only be a partial judgement...without litigating the other patents
did they say what patents are specifically invalid?
how many days for the purdue lawyers to respond? does judge need to tell them to respond by a date or is it automatic?
if you dont know rexista formula and manufacturing details how would they ever prove that unless they had their pills?
can they ask the court to have ipci turn over that info? in the next phase...
thats great news! can you provide highlights on each of the patents? at least the older ones...do we thermo press our tablets or use 25ppm if i remember right was some of the issues?
Samsa, I see a docket entry posted 5/17/201 on the Purdue lawsuit
Can you let us know what that's about?
Thanks,
Now it's Canada's turn......Seroquel ANDS under review by Health Canada
ADHD four dosages.... Due to hit the market NLT June 30th
ANDA#202939 A poster on Ipci.ca actual captured the screen image of the stealthy approval or should I say our unfortunate fake news on May 1st.
Wim: I just meant approvals get legal review and with the petition I am sure if that's the hold up some lawyer needs to sign off that this anda isn't material to the petition since Ipci isn't seeking any 180 exclusivity period besides its OBE.
Next week we could consider filing a freedom of information request for any communications between April 25 and May 5 that was relavent to why anda was posted for approval and then removed from the drug approved web site but you might have to pay to get this request processed but it definelty gets elevated to management and legal.
At this point the company is trying to get to the bottom of this fiasco so by next Monday COB I would be very worried if no resolution... We might need to stArt hoping PAR gets thier additional dosages on the market soon.
I haven't received an FDA response but I am not expecting one, the best we can hope for is the anda number gets relied to a manager who internally tracks down its status.
It's very unlikely it's a database issue at this point. My experience is a PR gets released then we see the database entry at least for p3 results in which the stock gets halted.
The best case scenario from postulated causes of delay is additional legal approval by FDA due to citizen petition that's open until August for comments.
At this point we are in a holding pattern for patent lawsuit, tentative to final approval cluster fxyz resolution, additional approvals...at least I have my hockey still in the playoffs to divert my attention from waiting for Ipci news!
you should fda email too
druginfo@fda.hhs.gov
provide anda number and state their is an database issue on their website site anda # approved from last week now missing.
..then we need to find this idiot and have him widthdraw the OBE petition...
IPCI lack of planning is going to sink us if we don't get shipping in the next couple of weeks!
Isn't the issue of legitimacy of Par's 180 day OBE since 180 days has passed?
there was one May 8th drug approval on fda site now gone
https://www.fda.gov/Drugs/NewsEvents/ucm130961.htm
Possible Delay reasons
1 Accord Healthcare Inc. 400mg do we really know they started shipping this dosage the same time as PAR? Why wouldnt the FDA at least allow the lower dosages?
2 new FDA head required all final approvals to be signed off by him..with other approvals later in the week this doesn't seem plausible
3 FDA never provided the company the official fax of approval so don't think it's a hw/sw issue (unlikely)
4 company owes FDA something outstanding (unlikely)
5 label change on original drug resulting in update of generics before approval
6 FDA is incompetent
7 plant re inspection issue ( unlikely company would have to notify investors
8 other
The Lost Week......that about sums up how I feel. I did go back do ensure PAR actually did announce shipments began..
http://www.handapharma.com/news.html
This is quite perplexing but hopefully we will look back next week and say remember the week the FDA forgot how to count...??
P3 results....why are the 4pm medium changes less than 2mmhg? Most the other times it's a clear +2mmhg.
They clearly show Timolol works.
9 more lawyers .... Seems a little excessive!! OJ dream team only had five lawyers...
I see there is another Docket Entry: 04/28/2017 can you see what that's about?
Monday should be interest we have to start trending up.
If a partner won't come to them they need to approach potential Lyrica partners. I would hate 14months go bye and with more generic competition we are right back to living Qtr to Qtr financially and no movement on key pipeline products.
Lawsuit was terrible news definitely pushes back a launch date if it takes 14 months to resolve.
I can't access it but it does appear there was a docket entry on 04/25/2017 regarding the Purdue lawsuit does anyone have access to this info?
Lyrica .....the patents appear to expire on Dec 30, 2018.....why not just file an ANDA?
You don't have to worry about the $20m and the drug being a generic sells itself literally.
I just think why improve the drug if you can't find a partner to fund the trials and then the NDA drug will need a strong sales force when you can get a few million a month as a generic.
Just a penny pitching thought....
Cost recovery.........
Does anybody have more insight into the $11m cost recovery aspect?
I assume this is for all the previous development work done on this drug leading to approval......can they get this back in the first 6 months or is it over the ten year period?
did the court assign a case number?
FDA has to be making process on one or more IPCI ANDAs
Effexor filed in Jan. 2010 or Pristiq filed in 2012 would be my guess for the next approval.
I started the year thinking an approval every two months but the last two approvals were closer to a 5 months interval.
Feb. 24th, 2017
Oct. 7th, 2016
launch all or some of the strengths ... It sounds like they might not have all dosages ready to go....I didn't catch that during my first read.
Odidi convertible loan $1.3m is still there on the balance sheet as expected.... why they didn't extend the loan date to December ill never understand...??
1st QTRY results out
http://finance.yahoo.com/news/intellipharmaceutics-announces-first-quarter-2017-224848896.html
Overall I am pretty happy cash until July we just need PAR additional ADHD dosages and Our big launch in May.
I would rather not have employee stock options until the company is profitable but that's the norm.
I am expecting another ANDA approval in the next 45 days.
At a 60,000 ft level not having read the patent details in detail ....it's all about who filed first and it appears Purdue has an US patent addressing abuse and another patent on gels earlier than any Ipci patents. Ipci has earlier extended release patents.
Purdue 1) 8,309,060 - '060 ABUSE-PROOFED DOSAGE FORM, issued on November 13, 2012 which is early than
Ipci issued on July 14, 2015 9,078,827 Pharmaceutical Composition Having Reduced Abuse Potential
We know Ipci uses a peo hope it's not covered by...purdue's 2) 9,060,976 - '976 PHARMACEUTICAL FORMULATION CONTAINING GELLING AGENT, issued on June 23, 2015
I am not liking the patent date alignments. Purdue definitely has some referenced earlier patents.
Ipci first USA patent with the word "abuse" issued 2015 according to annual report.
U.S.A.
July 14, 2015
9,078,827
Pharmaceutical Composition Having Reduced Abuse Potential