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Hey Doog, looking better today. Perhaps the flush is over?
"You say that you have superior research and understand more than everyone else but you don't."
Inane comments like this, which is something that I would not make, is why "analysis of the facts" would be something an objective might be able to do if they weren't reading into those "facts" what they want to.
I'll agree on one point. It's not important! I'm done.
The problem with people like yourself is you like to dance between generic comments and specifics and call it the same thing. Also to and fro, before and aft, etc. and in between are generally different to most people with potential different outcomes.
There are loopholes in the aftermath of the approval process which has perhaps been exploited and perhaps not. I have previously offered an alternative opinion once before but I doubt conspiracy theorist (while perhaps an option) would except an alternative.
So I'll naively leave it alone.
Well, you're entitled to your opinion. Any political hand-wiping is speculation at best. I was dealing in reasearch.
First, all 3 companies took 6yrs from filing to approval which contradicts your guesstimate doubting any big generic company going past 5 yrs for approval as you singled IPCI out for.
Secondly, the approval process awards the first company that has
all the pertinent info they're looking for via CRL's as complete taking into account patent expiration dates, exclusivity agreements, etc.
Also I saw a generic drug recently approved for 9 different companies on the same day both large and small once all the FDA criteria and timeframes had been met. While I didn't check, I seriously doubt they all filed on the same day.
No, not confused, just didn't say it correctly.
This stock is not marginal <$2/share.
Ok, I stepped out for the afternoon to go to the Auto Show and come back to a dump fest, lol.
Doesn't surprise me any. Don't know about other brokerage firms but TDAM doesn't allow margin accounts to purchase stock below $2 so if the other firms are the same then all around that $2 mark there was stops and exit strategy in place to take advantage of,imo.
Lots of shares traded in such a short range makes me think value players stepping up to catch the fall-out.
I think we both realize that if all the ANDA's that hit their 36 month timeframe were approved without a hitch we wouldn't be having these conversations.
What we all need to understand is the company now is in a paradigm shift in their business model.
They developed ANDA's in house with no outside exposure needed to do that with the small dilution.
They brought their NDA's presumably through phase 2 trials. Again in house because funding needs could be handled.
Now they're presumably ready to push forward without the benefit of the revs they envisioned would be in place, from their approvals, which haven't materialized as of yet. So exposure is now the name of the game to push forward. Enter Mr. Penna.
Oh, another thing, for those that think little ole IPCI doesn't have the ANDA political clout to equal the big generics, a little research goes a long way.
I wonder how many knew when IPCI filed their Focalin XR ANDA that "little" ole Watson and "little" ole Teva (global generic leader?)had filed their same Focalin XR ANDA's the same yr. All 3 received approvals within 1 day of each other 6 yrs. later. They must have had their heads up their collective arses as well and they're experts at the process,lol.
It must be easier to speculate to the dark side then to verify whether there's any validity to it.
All valid opinions/speculation is what this board is suppose to be about but do some research on the things you can, imo.
The press release went out through their pr firm.
Compliments from Doog.
PCG's clients in attendance include:
Actinium Pharmaceuticals
Anavex Life Sciences
Arch Therapeutics
Aeterna Zentaris
AtheroNova
Athersys
Capricor Therapeutics
Cesca Therapeutics
Cytograft
GeoVax Labs
Harvard Apparatus
Inovio Pharmaceuticals
IntelliPharmaceutics International
Lightlake Therapeutics
Lixte Biotechnology Holdings
Nephrogenex
Nephros
Prima Biomed
Protea Biosciences Group
Relmada Therapeutics
Soligenix
Unilife
http://www.reuters.com/article/2015/01/08/idUSnMKWNj5PKa+1e6+MKW20150108
While it's great to speculate about Mr Penna's employment and special skills he brings to IPCI (Incidentily, sprot, he must have called Teva to get Suzanne Brand listed on the website and his name removed after you asked him for his status) and whether or not we have some kind of partnership deal on the table ready to sign, we shouldn't loose sight about the recent J.P. Morgan Healthcare Conference the company attended. As 1 analyst stated:
"Cheryl Swanson: There's a good reason the JP Morgan Healthcare Conference is often called the Super Bowl of healthcare. It's the biggest healthcare meeting of the year with pharma giants and small/mid-cap biotechs huddling up to listen to presentations and talk up deals."
So clearly the added exposure was there to get there story out to a potential partner (if none existed) or evaluate added interest or a better deal if there truely was something on the table prior to the conference.
Just an added thought here.
In addition, I think it would be a good practice to research out the ANDA process and the changes that the FDA has implemented over the yrs which affected the business plan of IPCI, since inception, and other big generic companies along with the role of a marketing distributor. Perhaps that will help with the understanding not conjecture, but, I agree, do little for the ANDA wait.
Having said that, much activity with Wyeth on the Protonix labelling front as I've mentioned with Effexor once before. Both are our oldest in the loop.
Probably best to use his own quote before correcting him.
"but I wish who ever is filling my BID ORDERS a little at a time would of Filled my $2.25 and $2.20 Bids for Over 35000 shares instead of this up and down all day Just Dump them"
No, that's not necessary. When Teva got a new CEO a couple of yrs. ago I believe he stressed cost cutting measures as the stock was just languising and just recently getting back to where it was yrs. ago. One of the quickest ways to do that is consolidate the organization to do more with less people. So it may nothing more than a numbers game starting with management and working down, imo. I just like to dream a little.
Edit:
However IPCI came about acquiring Mr. Penna's services I think the organization is better for it, imo.
Thanks, sprot. Keeping the website updated was my most likely scenario but I'm a sucker for conspiracy theories, lol.
I have expressed similar thoughts but it can be anything from a lack of website clean-up to a merger which would only happen if Dr Odidi's number is hit.
Internal promotions/reassignments in large companies don't surprise me with no press releases especially when we're talking about a subsidary (Teva Canada/Teva Americas) of Teva Global. So perhaps that's the same way with resignations IF that's the case.
Note that Ms Brand received a Senior Director position in her field of finance from Director with the company for the prior (4) yrs until 7-14. So my belief is Domenic was training her to fill his shoes, he leaves Teva 8-30?, Shameze resigns thereafter with Domenic in route to IPCI.
I personally believe he was her boss. So she either has an opportunity to prove herself as his permanent replacement or gain the experience needed as his backfill until someone else assumes the position.
Of course, I prefer the merger theory and he's coming back. Otherwise a licensing deal will work also.
Is this a capitulation dump before the news?
Nice Doog. Let's hope something significant is announced at the conference next week.
No the pipeline listing hasn't been updated on the company website so it isn't updated in the I box either but yes an additional ANDA has been filed.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=108955874
Nice, when was the last time we saw the bid higher than the high of the day WITHOUT any news.
Nice Doog, bought more yesterday and today. Chart looking nice with a SAR flip today.
Some renewed focus on the ANDA front folks. More focus on approvals not response letters with a new appointment which came out (2) days ago.
WASHINGTON — In a staff memo, the Office of Generics Drug’s acting director, Kathleen Uhl, vowed to take action on 90% of the abbreviated new drug application backlog before October 2017, and has appointed Ted Sherwood as acting director of OGD’s Office of Regulatory Operations to help with the improvements, FDANews.com has reported.
“To get to a steady state, we will focus on approvals not actions, and make other business process improvements, to improve our productivity and communications with respect to the pre-Year 3 workload,” Uhl stated in the memo. Uhl noted that additional details will be coming in the next few weeks.
According to the report, generics makers have worried that the Food and Drug Administration sees its GDUFA commitments only as issuing complete response letters to satisfy performance goals under the law.
At its peak, nearly 3,000 ANDAs sat on backlog, which consists of ANDAs filed before GDUFA established performance goals that went into effect Oct. 1, 2014, according to the report.
FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs
Office of Generic Drugs to Focus on Approvals in Addressing ANDA Backlog
The Office of Generic Drugs is pledging to catch up on a backlog of thousands of ANDAs by October 2017.
OGD head Kathleen Uhl outlined this goal in a memo to staff recently that stresses the office’s role is to approve as many applications as possible, and not simply clear the backlog by issuing complete response letters. Uhl promised further details in the coming weeks.
Attorneys who work with the FDA on ANDA submissions welcomed Uhl’s announcement, especially her emphasis on approvals.
Generics makers have worried that the FDA sees its GDUFA commitments only as issuing complete response letters to satisfy performance goals under the law, said Kurt Karst, an attorney with Hyman Phelps & McNamara.
The FDA understands the industry’s concerns, said Bob Pollock, a senior adviser at Lachman Consultants and former acting deputy director at OGD. The question is not whether the FDA knows what it needs to do but whether it has the resources to address the backlog, Pollock said.
At its peak, nearly 3,000 ANDAs sat on that backlog, which consists of ANDAs filed before GDUFA established performance goals that went into effect Oct. 1, 2014. These goals eventually require the FDA to take action on 90 percent of ANDAs within 10 months.
The FDA has said it has already made progress on addressing the backlog, assigning most applications target action dates. However, the agency still has a long way to go, as average ANDA response times now stretch past 40 months, Brian Malkin, an attorney with McGuireWoods, said.
In addition to the backlog, Uhl’s memo noted that she has named long-time OGD official Ted Sherwood to serve as acting director of OGD’s Office of Regulatory Operations, a move Pollock called a positive development because Sherwood has a track record of moving applications through the bureaucracy.
Read the memo here: www.fdanews.com/12-15-2014-OGD-Memo.pdf. — Bryan Koenig
http://www.drugstorenews.com/article/report-office-generic-drugs-pledges-take-action-anda-backlog
"...it does make logical sense why the former TEVA CFO would jump ship from 1 of the worlds already established bio-med giants to join the still burgeoning bio-med MONSTA in the making IPCI at this time!"
Another point. Teva's share price is back to where it was (5) yrs ago with the O/S doubling in the last (9) yrs contributing to the decline as well. With Teva @ $57 and IPCI @ 2.30 who has the opportunity to double in value quicker assuming the known potential value of the company behind the numbers?
Also with his knowledge of how the generic approval process was and how the process has evolved since GDUFA was implemented in 2012, I believe he knows that the (3) ANDA's we submitted in 2010 and the (2) we submitted in 2011 probably cleared the most important chemistry process and have been on hold until all the supporting "window dressing" is in place to the FDA's satisfaction.
One major point I picked up on recently as well. Notice the ANDA's have numbers asigned to them upon filing. I've narrowed the numbers down to around 201309 to 202161 to encompass the (3) ANDA's we submitted in 2010. Those that have been looking at the monthly approvals on the FDA website should see a noticeable increase of approvals above our 202161 number (203..., 204...,205... etc.) These have been filed and worked to approval as they work up to the top and everything checks out. Our (3) have been reviewed at least once and Domenic knows where we are at. Count on it. The good news I've discovered is when the company responds back to the FDA, the lowest ANDA# is pushed to the top as evidence by Pfizers last reply in early Dec. and FDA response on the 17th of the same month showing approved. Pfizer's ANDA# started with a zero, lol.
Yes, nice. I noticed that once before as there had to have been a connection somewhere to lure him away.
I believe they both knew each other, worked together, and both were instrumental with the ratiopharm merger with TEVA.
http://investing.businessweek.com/research/stocks/private/person.asp?personId=134190248&privcapId=4240255
"So in a nutshell the original patented drug manufacturing co's have been spending several months trying to get the labelling right/correct with the FDA before the FDA even asks the generic co's to submit their required labelling amendments/revisions!"
Yeah you got it Doog. While our only example of an approved ANDA is Focalin XR,as investors we shouldn't make the mistaken timeline comparison that Focalin XR went through. IPCI got the most difficult ANDA to approval than any drug in their existing pipeline. Examples are: (3) lawsuits to address, (6) different strengths, ADHD Novartis info revisions I'm sure contributed to the delayed timely filing entry to give TEVA, Watson, etal, the edge as all were approved almost simultaneously, the delayed launch of (4) of IPCI's strengths due to the cluster of timely approvals and shortage of supply of the active ingredients with marketing schemes to boot.
No, we won't have that quagmire to wade through with the next (3) ANDA's. All have patent expirations, all have generics out already, no abuse concerns that needed addressing like ADHD and opoid drugs eliminating the cluster of entrys to approval, etc.
Once IPCI gets response letters on things like labelling (if they haven't already) the most difficult part of the review, which is the chemistry, has to give the company a sigh of relief that all is well from a drug development standpoint and now with the patented company being "correct" they are now dealing with upgrades, revisions, format changes, etc. and approval is imminent. Too bad we can't see the exchange letters to note the progress and interaction.
Also I have to agree with you with little ole IPCI picking up a CFO from a large generic company like TEVA with the positions, and undoubtedly, the salary he had. Must be something he likes.
Hey Doog, timely response as I have some good dd to share on the ANDA front which is what our frustrated focus has been while IPCI advances the NDA trials.
I'm sure I speak for all of us that we expected a little quicker ANDA approval timeline then we've seen thus far. Most have taken the "delays" quite well as inevitable.
Consumer/prescriber knowledge is at the forefront of our dilema when the FDA enacted new labelling guidelines well over a yr ago. Another added delay to an already growing ANDA backlog.
As I recall when I read some of the info awhile back the generics "can't" get the labelling "right" until the original patented drug is correct. After 2006 the labelling has to be correct upon submission of the ANDA with notification to the original drug maker to get it "right" based on the new implemented guidelines.
At the time, this didn't sink in until I just verified it today. Luckily for me I noticed Pfizer/Wyeth's approval for their labelling compliances to the FDA letters which has been ongoing since the changes went into affect last yr. I found supplements dated from 4-26-13 from Pfizer to the FDA and several response letters back to Pfizer since.
One example dated 5-13-14 from the FDA to Pfizer is they wanted to "label for drug to treat major depressive disorder" and add "the risk of angle-closure glaucoma". The 40 page pdf file (yes 40 pages)approved on 12-17-14 recently had those revisions in there.
The point is Effexor XR was approved in 1997 and the FDA is still dickering with Pfizer to get it "right". By the FDA's own guidelines generic companies won't be allowed to get the needed amendments/revisions in until the original drug manufacturer you're comparing yourself to get's it "right"
Also it would be great from an efficiency standpoint if the FDA would address ALL the issues they're concerned about in 1 response letter instead of the way they're handling it based on the exchange of info I saw.
Thank God we aren't at least dealing with a comparison company that's went out of business that would be a whole other ball game, lol.
So I thought perhaps 1 or 2 people might appreciate knowing the reason why we're waiting longer than anticipated. Hopefully they're through with Pfizer and they can concentrate on companies like IPCI submitting Effexor XR generics now that the grand master is, hopefully, "politically correct". If so, the exchange between the FDA and IPCI would go quicker. I didn't check on the other (2) oldest ANDA's we're waiting on just wanted to pass along what I found out.
Yeah mopar I didn't expect a big gain to stick as this has been under accumulation, imo. Up .01 as this has been the standard to run it some then pull it back to go through the same process the next trading day again but they ran it a little higher today. Obviously they are taking advantage of the lack of news and end of yr. selling, imo.
Nice to see a little upward action today. Hope everyone had a great Christmas yesterday.
Have to admit Tony I didn't realize they made a drug for the overly cheerful. I guess I haven't ran into those type of people, lol.
Yeah, it's all about timing. Still a very nice profit but it's hard to keep from looking back on the good ones.
I know we all know this but it doesn't hurt to amplify it. The steep drop we had back in July, due to the bogus downgrade and lack of recovery, put the people who bought earlier in the yr at a significant % loss so in a rising stock market yr, I'm sure offsetting those gains with losses is being implemented and lower bid support is just taking advantage of it also on the cheap.
My 2 cents.
Ok hog, I'm worried about you. I may have spewed coffee but you spewing beer 24/7?, lol.
Tired, since you at least make an attempt to make cordial posts through your anxiety attacks I'll make an attempt to reply at least once. Any future communication will be on further displays of listening then expressing your opinions as you see fit. I doubt I'll have the ability to ease your anxiety because it's based on the present share price not the circumstances of why we're at this level. While I've stated the communication could be better with this company, it's also not their responsibility to issue pr's to "prop" the stock price up.
Having said that the stock performance is basically a reflection of the "low hanging fruit" approvals being delayed yet further out then when this company embarked on this strategy many yrs ago and particularly the flawed system not allowing all of the Focalin XR strengths to come to market at the same time. This was a severe blow to their earnings which undoubtedly (based on present market share) would have made them cash flow positive and would, of course, would have allowed them to progress the business at a faster clip and eliminate share dilution of which has been minimal,imo. Once they realized the scope of the FDA backlog, increasing their focus was just on progressing the NDA's, which we've been given a recent update recently, as evidence of only 1 ANDA, recently sumitted, in well over a yr.
The cumbersome way in which the FDA functions allows you to make flawed assumptions on the approval timeframes and also you don't allow for the major changes the FDA has undergone in just the last 2 yrs. The agency is quite a different animal then when this company put it's business plan and strategy together so many yrs. ago.
I'll leave you with one example, (2) different companies received approval for the same drug on the same day last month but 1 company filed their ANDA on 12-11-09 with a CRL issued on 2-10-14 and amendments on 3-14-14 and 5-20-14. The other company filed on 9-30-11 had a tentative approval date of 5-27-14 with amendments on 9-8-14 and 10-6-14. Both cited dismissed court cases on patent infringement of the original drug still in patent. Note the submittal dates and also note the next 3 approvals we are waiting on were filed/accepted in 2010. Not a level playing is the point and trying to put a timeframe on any of these is speculative BUT they're at the forefront of the list such that it is.
Should you want more exchange of ideas then take 1 point at a time and let me know. Again, the share price can be driven downward because of our situation, not from the company's lack of performance ,but from circumstances outside of their control hence the heavy short against the company. Having said that I noticed 50k shares absorbed at 2.38 without dropping further so someone likes where we're at. We are close to a phase 3 deal(s) and the're investors who know this.
Still haven't removed him from the TEVA website. I guess without a pr no-one got the memo, lol.
That sharp drop (2) hrs. ago had something like 40k shares dumped in a couple of minutes. They were sucked up quick then bid returned. One can assume we're being absorbed at these levels.
He can serve ice cream and coffee along with that deal at any time, lol.
Well, I think we all know hindsight is a wonderful thing, right hog? But all we can do is utilize the info we have available to us at the time and try to time our entrys appropriately.
Unfortunately, as we all know, conditions change, which our crystal ball didn't pick up on, and we're faced with deceisions along the way.
Fortunately for me I used the Buffet approach. If I liked IPCI @ $3 then I really liked it @ $1.56 and bought more since the company fundamentals were unchanged, just the stock price reflecting impatience, doubt and fear.
I believe the short position of 1.14M shares is probably accurate based on the waiting game we're playing and players taking advantage of it.
That said we're in for a nice move upon significant news.
Yep, when things drag on the anxiety attacks come forth. The bottom line is we were severely derisked when we received our only ANDA approval over a yr ago.
For those with the ability to analyze all the variables that have impacted the company's present disposition of where we are at and why, it can at least give comfort while we continue to wait.
Having said that, both our NDA's are at or near phase 3 clinical trials and I'm sure they're negotiating partnership/licensing deals as we speak.
As someone prudently said once before "it's not IF it's WHEN".
I'll agree that communication could be better but this isn't the first company I've been associated with that want communication to be about pertinent results and activity not updates especially when they aren't cash flow positive. That's always the rub between individual investors monitoring their portfolio often and companies pushing their business model forward with the stock price as a secondary concern.
BTW, we had a nice bounce off of the 27-28 RSI this morning.
Massive reversal on all the technicals including the IBB didn't hurt, lol.
Well, we can dream Z. While I'm not an advocate of conspiracy theorey's, and realizing website updates lag behind, I find it curious how Shameze was deleted after a few days from the IPCI website but Domenic has yet to be listed. Perhaps they're waiting for TEVA to delete Domenic first as that hasn't happened yet either. Ok, encore, dream some more.
It was probably early September as it wasn't in the 2nd qtr. report. There was a complaint filed on it about 9-26 but it didn't make the press release like the one Pfizer filed on IPCI's Pristiq in August. Neither of these has been formally served to IPCI and they have been settled before with other companies should they go to court. It's showing a market of only $2M for the drug which I would think is an error.
Incidentilly, this isn't the first time a pr wasn't issued on an ANDA being filed.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=97584653
Phosphate rock price remains unchanged at the end of November @ $115/mt.
Yeah I was watching at the time Z. Never can understand these people that watch all day long at higher prices and when bid support is pulled for a few minutes, before the close, decide to dump about 5k shares quickly. Go figure!
Before everyone gets away for the holidays. I hope you/yours have a great Thankgiving!