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Hey Doog, long time no see, lol. Just checking in as we both had been in this company for 5-6yrs. I had made the decision to unload completely upon the Glucophage acceptance run-up on 2-24-17, in the 2.55-2.85 range. Coincidentally that was 1 yr. to the day that the Keppra acceptance was announced with no movement on commercialization of that product. I wasn't optimistic about Glucophage fairing any better with the companies history. At my peak I had well over 300k shares so the run-up helped me unload as we were around the $2 range previously.
I had bowed out gracefully still hoping this company could turn the corner for the sake of the good people still invested here. I will say for the record I did not envision the Adcom results but it most certainly reflects a pattern.
I guess for me, being invested in a company for so long, I let my vision cloud my better judgement. That being said my best to those still invested here. I think new money can make a profit at these levels in due time.
Looks like our day in the sun has arrived. My congrats to all the long sufferers as well.
Good catch with the shares. Who knows? Perhaps someone thinks with this much volume something's brewing just like us and willing to pay a premium prior to a Monday open with potential news.
Anyhow have a good weekend!
Hey Z it could be worse. I've got a constant fog that I can't break through at the #5 spot
Perhaps I can chime in stock quotes throughout the day to get my post limit. That ought to do it.
At 2.90. Instead of Gorbachev "Mr Odidi, tear down that wall"
It's all oregon's fault, I just followed, lol. Buying continues every 42-43 secs., if the bid isn't hit. What's not to like?
A program(s) is running buying shares at 100 share lots every 30 seconds currently.
You as well!, eom
Yep definitely feel your "pain". 5+ yrs. for me. Who would have thought the FDA quagmire would have impacted us to this degree but as you say our days are numbered now.
Good deal, oregon. Bought yesterday as well anticipating good acceptance results. Between us I guessed we cleaned them 2.72's out, lol.
Yeah I've been noticing that. They're buying them continually. Grabbed some myself.
Also good news on the ANDA front.
The FDA notified Wyeth as the NDA holder of Effexor and Pristiq in Sept., to update new safety information in regards to serotonin warnings and precautions. They responded in October and FDA approval just came out 6 days ago. Both of these drugs are affected by the same update change.
The same day 1 NDA and 11 ANDA's, which have made similar changes, were approved as well in regards to Effexor. A few more companies followed with Pristiq updates, all addressing the same issue.
The 12 addressing Effexor all had initial approval dates from 2006-2010 only. IPCI's filing was accepted May, 2010. I can't help but feel this one is close at hand.
Our Pristiq partner, Mallinckodt, I'm sure is noticing and it would be great if they were interested in Effexor XR as well since it isn't part of their portfolio yet.
Morning Doog, the 25 and 35mg Focalin XR strengths are now listed on Par's product catalog as available even though they/Endo didn't pr it.
Looks like an official go!
Ok, bids starting to creep up. Someone's decided no ones going to give the shares away at this point.
Great news Doog. Nice that IPCI puts out the press release before Endo.
Great strategy also, launch the exclusivity dosages first $$$$$$$$$$$$$$$$$$
Nice post Z. Here's to a great year!
Here's a thought I had once before which I think may be appropriate since we know Par has the ability to manufacture the tablets.
Since the drug is a controlled substance, the DEA may have allotted it's quota for the time being and Par is trying to get enough to launch. As previously stated the DEA had thought there was adequate supply and the FDA was taking the opposing view. Perhaps that's still an issue.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=107419789
Mike, like you I have been monitoring the website for the news release and catalog updates so, yes, it doesn't appear a launch has happened yet.
Imo, it appears to me all that is owed IPCI at this juncture, as far as actual milestone payments, is the 5, 10, and 20mg strengths upon approval and the other stengths upon launch.
Unless, of course, I misunderstood the agreement.
I have no doubt they've addressed that amongst themselves. It's just not available for public disclosure.
Amendment and Restatement of Section 6.5 of the Agreement
Section 6.5 is hereby amended and restated, such that the current provision is deleted and the following is substituted in its place as of the date hereof:
6.5
Exclusivity Milestone Payments . In addition to the milestone payments in Section 6.4 above, Par shall make the following milestone payments to IPC, in respect of the 5, 10, 15 and 20mg strengths only, on a strength-by-strength, one time per strength basis, in the event Par makes a Commercial Launch with a Generic of the Brand Product (whether under the IPC ANDA or Par ANDA) or Authorized Generic Product in any such strength:
6.5.1
In the event that such product is the only Generic of the Brand Product or Authorized Generic Product in that strength commercially sold in the Territory (i.e., there is no Generic of the Brand Product or Authorized Generic Product in that strength commercially sold in the Territory other than that sold by or on behalf of Par or a Par Affiliate pursuant to the Agreement) for a number of days (N1) up to one hundred and eighty (180) days during the period commencing on the Commercial Launch of that strength and terminating one hundred and eighty (180) days later, then Par will pay to IPC the fraction of [ *] Dollars ($ [ *] ) that N1 is to 180. Such payment shall be due upon the later of (i) one hundred and eighty (180) days following the Commercial Launch of that strength, or (ii) a non-appealable decision from an appellate court ruling or a district court ruling from which an appeal can no longer be sought of non-infringement or invalidity in favor of Par in a patent litigation regarding that strength of the Product between IPC and/or Par and the owner and/or marketer of the Brand Product.
6.5.2
In the event that there is no more than a single third party competitor to such product in the Territory (i.e., there is no more than a single Generic of the Brand Product or Authorized Generic Product in that strength commercially sold in the Territory by a third party other than that sold by or on behalf of Par or a Par Affiliate pursuant to the Agreement) for a number of days (N2) up to one hundred and eighty (180) days during the period commencing on the Commercial Launch of that strength and terminating one hundred and eighty (180) days later, then Par will pay to IPC the fraction of [ *] Dollars ($ [ *] ) that N2 is to 180. Such payment shall be due upon the later of (i) one hundred and eighty (180) days following the Commercial Launch of that strength, or (ii) a non-appealable decision from an appellate court ruling or a district court ruling from which an appeal can no longer be sought of non-infringement or invalidity in favor of Par in a patent litigation regarding that strength of the Product between IPC and/or Par and the owner and/or marketer of the Brand Product. For the avoidance of doubt, the payments contemplated herein at subsections 6.5.1 and 6.5.2 are cumulative on a strength-by-strength basis, provided that the sum of N1+N2 for any one strength shall not exceed 180 days commencing from the Commercial Launch of that strength.
Looking good! Bullish PSAR flip with upward momentum.
Well, I usually don't take any credit for my buys but I just cleared out the rest of the 2.81's on the ask. So we'll see if that was smart or not!
"pond scum" I like that term Z. I've always felt shorting is legalized "rape" of the small investor, running stops, etc. The advocates claim this creates a market and balances trading. The only thing it does is redistribute wealth to where it already is. It also allows large positions to unwind themselves and load back up at others expense. Normal buying and selling at what the market will bare is sufficient but that might unwind a whole lot of wealth out of all the greedy individuals and financial institutions prospering from this activity. We obviously can't have this now can we?
While our focus has been on the NDA lately, there has been a massive amount of NDA and ANDA labeling approvals this month particularly on the 16th and a large percentage of those in the opioid market.
Even Demerol, a 1942 NDA has been upgraded. I'm sure this and the recent requirements that were implemented the 6th of this month had significantly impacted the filing timeframe of our NDA to ensure an acceptance letter in format/content and a later drug approval based on proof of concept supported by patent claims.
Yes fabius an earlier time is always possible but I think the idea was to anticipate the norm as opposed to a quicker response but I'm sure I speak for everyone, like you, that earlier is better
Thanks cysonic. They presented last yr. after market closure due to the time difference on the west coast. Now that they have great news to pass on with the NDA filing and patent in hand with a potential partnership, which could be exposed beforehand, let's hope they get an earlier presentation time.
Either way, they have more to offer than before.
Looking good, bid keeps building, ask gets hit regularly.
Yeah, we're in that sweet spot. It'll be interesting to see whether they'll let it fall back at the close but closing above the 50 @ 2.84 will set up another attack on the 2.90 area.
Hopefully we'll blow through the 2.90 area before the close and won't look back.
Wow, look at that bid climb. A close above 2.84 would definitely be bullish!
Curl up baby, curl up, lol.
Hmmm, 2.81 on the bid?????????? Say it isn't so?
Ooops, back down, looks encouraging though.
Hey Z, I think we're all hopeful a deal is already "inked" as you say rather than a standard LOI. It may be structured to incorporate acceptance of the patent and the NDA filing prior to an upfront payment. For me the patent was key to close this deal officially as a potential partner may have been involved in reviewing the NDA before submittal. At this point, to get more bang for the announcement, like you, I prefer they wait until after the holidays.
Should January drag on without an announcement then it might be evident that the February acceptance letter will come into play. We don't have prior history that any generic filing by IPCI wasn't accepted prior and we know of Dr. Odidi's background which lends us to believe everything will proceed accordingly. The first NDA submitted by IPCI "may" be under scrutiny until that track record is established. Just musing "aloud". What else do we have to do while we wait, lol.
Having said that, here's to a deal announcement Jan 2nd!!!!
You go grasshopper!
I feel like I was in a kung-fu class listening to an old Chinese proverb.
Sounds appropriate though.
Better get this in before another Ihub misfire.
Great news Doog! Although the share price is being manipulated for accumulation, this technically puts a floor, without reservation, that the public knows officially the company has something unique to offer upon proof of concept but the "official" word is now out.
Another step to a concrete deal. Another thorn in the side for those making an offer to up their bid. If no deal before the acceptance letter from the FDA it will just add fuel to the fire.
They can control the stock at present but that to has an end.
For anyone who may be interested, as I speculated prior, the FDA website is a little behind on their approval listings. IPCI is now listed as a T/A on all their strengths of Seroquel XR as of 10-7-16.
Also, as a further demonstration of FDA efficiency, Handa is now listed with all their strengths with T/A and no approvals of any strength. Well, let it not be said that the FDA is on top of things, it's a 2010 notice that should have been listed 6!!!!!!! yrs ago. They'll find the updated version with their recent approvals, perhaps say.... 6 yrs, lol.
So if this info is anything to gauge by as a Seroquel XR update, it would appear Mylan and IPCI will join Handa and Accord in 6 months and share at least 6 months of profits until we see if other players will be in the mix 11-1-17. At least that appears how it shakes out at present.
Nice grill, that actually came out this morning as they always post them a day late. I also looked last night and none of the 13th approvals were listed, as the norm. Regardless, these last (2) were both filed after the IPCI submission which bodes well for our future approval.
People mistakenly enter market orders all the time and now that it's the end of the tax yr., inconsequential amounts, such as these, to clear out a position isn't unusual. Pre-market and after market are generally low ballers paradise anyway but you generally can't buy in size.
If you notice the pre-market yesterday morning had a sale(s) in the low 2.60's but never came close to that during normal hrs during the day.
I can only assume if the after hrs. trade yesterday was higher than the close, it wouldn't have been an issue. Selling at $3 for potentially a couple of MacDonald's double cheeseburgers extra wouldn't be a big deal to most.
Yes, I was just pointing out progress is all. The same can be said for Protonix. We use to have a male nurse here (hogfan) that stated they gave it out like candy but again, every little bit helps.
Approval given (2) days ago to another company for metaformin hydrochloride (Glucophage XR) filed well after IPCI's entry.
Bodes well that they're working with IPCI's entry to get it "up to snuff" versus the NDA holder.