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I was hoping for a bigger run on this news but I guess with no means of generating revenue people are looking at ut without much excitement.
At least we can see the fda is moving.. Maybe they will look at getting partnerships done on the other drugs so they can generate revenue on approval now that they see fda movement.
ignore my last post was looking at something else :P
So this wasn't a labeling revision or anything that had to be sorted out. It says it was a Manufacturing Change or Addition. Assuming it was a change in manufacturing why would this have been holding up our generic version of Keppra?
A whopping 6 shares traded on tsx... No movement...
Are they going to release a PR for this? Seems like something you would like to announce
Well as the saying goes, show me something idiot proof and I'll show you a better idiot. Drug addicts are the same. But as of now... The way I read the patent is very promising.
They tested it on all sorts of drugs... Blood clot drugs, codeine, adhd drugs...
So basically from what I can see. The active ingredient is coated first with Methacrylic acid, then magnesium hydroxide. (few more ingredients involved but those are the major)
So stomach dissolves the magnesium hydroxide which will lower ph levels. If its the single pill then the effect on stomach acid is negligible enough that I will still dissolve the Methacrylic acid and then the active ingredient. If you swallow two or more pills, then the amount of magnesium hydroxide released is great enough that it lowers stomach ph enough that it inhibits its ability to dissolve the pills any further...
I wonder what ability there is to possibly scrape off the outer coating....
87. The unit dose formulation of claim 69, wherein said at least one alkalinizing agent is present in said at least one alkalinizing coat in an amount such that: when less than a predetermined number of unit dose formulations is ingested, the gastric pH remains sufficiently acidic to dissolve said at least one acid labile coat and/or substance and release said at least one active substance; and when the predetermined number or more of the unit dose formulations is ingested, the gastric pH is alkalinized sufficiently to inhibit dissolution of said at least one acid labile coat and/or substance and release of said at least one active substance.
Read more: http://www.patentsencyclopedia.com/app/20160022590#ixzz3zfmJlS84
interesting how it works...
We'll see about that. Still not clear if that requires par to get that approved or not.
Given the increased communication and the last presentation that gave more firm timelines than 1st half 2 half I have more confidence in this company now. Seeing that they said June/ July for NDA filing is it likely they will have a partner before filing? And if that's the case then am I way off base in assuming they will likely announce partner during next quarterly report? Maybe to increase price in order to sell some shares? By end of Feb cash will definitely getting tight. Unless they sold some on the last run up a few weeks ago.
I like how they gave a more specific date for NDA filing of June / July
The tsx one will likely pull back tomorrow.
So are we looking at a 8-12 months commercialization from here realistically?
Cheers sprot... I'm hoping for a little tidbit to get ne green again and then I'm selling some off as well. I'll hold a much small position after.
will see. $2.00 doesn't look like its going to hold.
It's possible that it was the same presentation again. Different crowd
http://www.intellipharmaceutics.com/secfiling.cfm?filingid=1171843-15-6920&CIK=1474835
Got excited when I got the email but the realized it was only for another presentation.... At least they're getting out there and telling their story more...
FOCALIN XR
(NDA # 021802)
031 DEXMETHYLPHENIDATE HYDROCHLORIDE NOVARTIS Manufacturing Change or Addition 12/04/2015
Is that the labeling revision being completed?
Hopefully we get some news before end of year... Or I fear whatever gains were made on that run will trickle away.
I thought I posted mine but I guess it never went through.
I'm not overly concerned for a few reasons.
1) There should be two more doses of Focalin being approved shortly. This would likely make them cash flow positive on its own or at least very close to it.
2) Someone will correct me if I'm wrong but Focalin is a cyclical drug that seems to sell better during school year. So This and next quarter sales should be better.
3) Oxycodone XR NDA filing is expected to be Q2 2016. I'd expect some sort of agreement prior to that so hopefully an upfront payment of some sort.
4) Company has a track record of being extremely frugal. I think current cash position is expected to last to Q2 so we should be ok for one of those things to happen prior.
Rexista™ Oxycodone XR
Positive FDA feedback in May 2015
Rexista™ allowed to proceed with NDA filing
Rexista™ requires no Phase III trials provided we demonstrate bioequivalence
Previous Phase I Pivotals suggest bioequivalence conditions met
Rexista™ with PODRAS™ granted Fast Track designation by FDA
Clears up any muddy waters there for anyone still unclear.
Just because I don't jump up and down on every upswing doesn't mean I'm stomping my feet. I choose to temper my expectations. How many times have you proclaimed this is the month, this is the pop, this is the week? Because I don't get excited when technical indicators flip on a stock that I've seen the flip both ways 4-5 times in the year doesn't mean I'm throwing a fit. I choose not to wave my pom poms every up swing just like I don't come in a say the world is ending and its going to get de listed on every piece of negative news.
We've seen this happen before and if delays continue we will be right back down to 1.80 again. Pointing out that it needs some revenue generating news for these gains to hold is hardly a statement that is akin to stomping ones feet.
My position is the same. This up trend has happened how many times this year alone? 2-3 times we've had these big swings. Without any news the same thing will happen. We'll run up and then a few months later drop down again.
Me.
We've seen this before. Sure I'm happy we're on a run now. But I want gains that will hold. Going from Up 20% to down 40% to Up 20% again every few months is not my ideal situation. I'm not swing trading this thing.
Enjoying the ride for now...
Sure but we lost it all. Its great if I want to swing trade this. But I'm hoping for something more significant.
We can pass every technical indicator it wont matter without news... We need an approval. Period.
The only news I can see is anther conference presentation.. That wouldn't explain the volume.
That's a lot of volume for the Canadian side. More than the US side which is odd...
Another insider buy?
Would be nice to know if they are planning to license or are they planning to produce them their selves. Because with the expansion and building purchase will they have go get another faculty inspection?
Would be great if one of these hit so I could diversify a bit. To many eggs in the ipci basket right now.
I know I saw that. If they said by 1q 2016 or something id think agree. But the way fda moves I dont see it.
Well I'm expecting at least a dilution one more time. I'm guessing even if one more generic gets approved with no agreement in place I don't forsee them being able to start sales or get the up front payment before they run out of cash
You think it could be an issue with the survey from the sale?
well there is a notice.
Reads as follows.
CONSENT APPLICATION
for 22,30,50,60,70,80 Worcester +360, 380 carlingview dr.
File no: B23/15 EYK
To obtain consent to sever lot for the purpose of re-establishing existing lot lines.
Will be considered on August 13,2015.
yada yada.. with a phone number for committee of adjustment office.
Wonder why you would be severing the lot if it was not to subdivide the property.
I'm not holding my breath on the manufacturing facility.. I don't go to ipci.ca often. I'm pretty sure its a tonypro pump site. But someone posted that the owner of the building that IPCI is trying to buy is applying to subdivided it into multiple addresses.
http://www1.toronto.ca/City%20Of%20Toronto/City%20Planning/Developing%20Toronto/Files/pdf/C/C_of_A_Etobicoke_Agenda_August_13_2015.pdf
scroll down to #41
I might drive by on my way home today and see if I can see more.
#1 is my main beef. Things happen and they're out of the control of the company. But there is no reason to not issue clear guidance on what's going to happen going forward.
Doesn't mean there is going to be significant news. I hope so. But I'm not holding my breath.
Man this is painful to watch. I got lots of patience but this is pushing the envelope.
I wont be surprised if we do t get news until end of 1st quarter next year the way the fda is moving.