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once you believe a competitor has abandoned their 180 day exclusivity you are still sitting with a tentative approval. you must still go back to the FDA are request a final approval under one of those sections and basically say "hey, so and so failed to launch within the time frame can we have final approval" and we all know how that goes. hope that helps clarify
This is important to have readily available.
Can we have the moderator sticky it to the top?
http://files.shareholder.com/downloads/ABEA-43EQSZ/1665438433x0x912718/535FA8C8-DD8D-40EC-AAE2-66CE4CC7AD08/Dawson_Securities_Conference_October_20_2016_-_Final.pdf
upgraded by Zacks Investment Research from a “sell” rating to a “buy” rating
Looks to me like an institution coming in - $2.94 = +10% which is ringing bells on the momos alerts - let's see what that does.
Just waiting at 2,30-area.
That's exactly what I see in my minds eye as to what IPCI's chart will look like for the next year... and we will still only have approximately 40% institutional ownership... so if you get out then... you will still leave a lot of money on the table!!!
In my opinion Dawson James is the "dog" Della Penna got in bed with and who "gave us fleas"!!!!!!!!!!! and those fleas are what are manipulating the stock price... with the assurance they have by holding 1.5 million warrants - what a mistake. We will not be rid of those fleas until major funds come in and absorb the stock they short... and break their back by causing them to convert the warrants to cover.
dawson james securities complaints - 73,000 results - read'em and weep.
https://www.google.com/search?q=Dawson+James+Securities&ie=utf-8&oe=utf-8#q=dawson+james+securities+complaints
a much larger chunk of the sales revenue than they are currently seeing from the Focalin deal.
https://www.drugs.com/availability/
Focalin XR - 4 Manufacturers + Novartis - IPCI marketing 2 of 6 strenghts - you all know this one.
https://www.drugs.com/availability/generic-focalin-xr.html
Seroquel XR - There is currently no therapeutically equivalent version of Seroquel XR available in the United States. On November 1st 2016, 2 manufacturers will receive approval and IPCI will receive approval after the 180 days of exclusivity - along with 3 or 4 others.
https://www.drugs.com/availability/generic-seroquel-xr.html
Lamictal XR - 7 Manufacturers + Glaxo -
Manufacturer: ANCHEN PHARMS - Approval date: December 26, 2012 seems had Para IV
https://www.drugs.com/availability/generic-lamictal-xr.html
Pristiq XR - seems like 4 generic mfg. + Wyeth - could be more.
July 2015 the US Food and Drug Administration (FDA) announced that Alembic Pharms Ltd, Sandoz Inc., Mylan Inc., and Lupid Ltd had received approval to begin marketing the new drug product desvenlafaxine extended release (ER).Desvenlafaxine ER is the first generic version available for the medication Pristiq®.
Keppra XR - 17 Manufacturers since Sept 2011 + UCB - IPCI's approval, Feb 23, 2016 johnnie come lately on this one.
https://www.drugs.com/availability/generic-keppra-xr.html
Glucophage XR - 15 manufacturers + Bristol - generics for this have been around since 2004, but market is still $2.4 Billion and not likely to get smaller... so 5% market share would be 120 million for IPCI and partner.
https://www.drugs.com/availability/generic-glucophage-xr.html
Effexor XR - 10 Manufacturers + Wyeth
https://www.drugs.com/availability/generic-effexor-xr.html
Protonix XR - 16 Manufacturers + Wyeth
https://www.drugs.com/availability/generic-protonix.html
To add it all up and put it in a nutshell folks... with an aggregate market total of $5.5 BILLION... a measly 5% penetration equals $275 Million... given a 40% royalty which is likely since IPCI brought them all the way through approval - except Focalin - that equals $110 million in royalties - all of which goes to the bottom line... and since they will probably manufacture at cost plus there will even be a little profit on the manufacturing side... AND THAT IS ONLY THE GENERICS... the potatoes... the meat is Rexista and Regabatin!!! Sell your house... sell your car... sell your kids... buy more!!!
20K shares today makes you a millionaire in 3 to 5 years!!! ... OR SOONER
A big buyer could change that.
Are earnings being released today??? after market??? anyone know??? not that earnings are relevant to this company right now... it's the potential for future earnings that matter.
Would love to hang around and offer my 2 cents on what is going on... but it would only be gut feelings rather than outright knowledge - so you know what they say about opinions.
I promised my grandson I would take him fishing... and he comes first.
Catcha all tomorrow... and my WAG on closing price is $3.12
remember 20K shares today makes you a millionaire in 3 to 5 years... OR SOONER!!!
Early last year, drugmaker Mallinckrodt Plc spent $1.3 billion to buy a company that sold an injectable form of acetaminophen -- essentially Tylenol in a liquid solution
After Hours:
Shares 205,863
High $3.65
Low $2.78
Close $3.29
Pay attention here!!!
Mallinckrodt announced that it's buying Cadence for $1.3 billion.
The catalyst for the acquisition is painkiller Ofirmev, which was approved in 2010, but with roughly $100 million in trailing-12-month sales, it hasn't been a huge seller.
I believe Mallinckrodt manufactures Collegium's ADF Pain meds.
May well be who will manufacture Rexista for IPCI... and possibly even be IPCI's sales partner for the Rexista franchise.
Just a WAG... and certainly not my preference... but sometimes a smaller pharma will make the best offer if it sees, and wants, a product that could help it make that leap into the big time.
In addition, the agreement also provides for the Company to have a long-term profit sharing arrangement with respect to the licensed products.
Under the terms of the 10-year agreement, the Registrant will receive a non-refundable upfront payment of US$3 million in October 2016. In addition, the agreement also provides for the Registrant to have a long-term profit sharing arrangement with respect to the licensed products (which includes up to $11 million in cost recovery payments to the Registrant).probably handled as sales milestones The Registrant has agreed to manufacture and supply the licensed products exclusively for Mallinckrodt on a cost plus basis,on a cost plus basis... my guess 20% above cost... will help with overhead and Mallinckrodt has agreed that the Registrant will be its sole supplier of the licensed products marketed in the U.S.
6 million shares traded in 2-1/2 hours...
or better put...
500K shares each traded 12 times in 2-1/2 hours.
Immediate-release generic Seroquel sells for around 10% of name brand, which might be an indicator.
At around 5:00, I had written and was about to post that the Seroquel XR approval "fit" what may have been the "news to come"... but decided not to.
Didn't want to steal Doog's thunder, since he's been posting every day about us getting Seroquel XR approval any day now!!!
There you go Doog - hope you're back soon.
Perhaps the partnership was all agreed upon and dependent on IPCI getting patent approval on PODRAS - so once patent approval was in hand... the papers were signed - and everyone was so happy, they had a drink on it ... and then they had another drink on it ... and then they had another drink on it ... etc etc and before you know it everybody was so shit faced they forgot we're hanging and twisting in the wind here!!!
Angelo.....I agree it could be bad news. ... they decided to take the offer and now it will be up to the partner to decide when to file. so the news will be they inked a partnership
The halt was during trading hours... not after hours... and the stock was trending up rather than down... so if there was a leak it hinted at positive news, not bad.
Why would someone halt trading with 1/2 hour to go, if it was bad news... why would he be deliberately calling attention to himself if the news was bad.
It does not make sense to me... unless Della Penna is the dumbest MF that ever lived!!!
Geezzz - I hope we're not left hanging this way 'til next week.
Is Della Penna a masochist out to torture the shorts and the lllloooonnnnggggssss!!!
The little guy on my right sholder is saying that the price spike up before the halt indicates a positive leak... but the little SOB on my left shoulder is saying it couuuullllddd be the FDA decided they need to do a phase 3 after all!!!
I hate to be a party pooper - but I just can't start celebrating yet with a full and open heart!!!
This is torturing me!!!
Pulaski NY - to fish the Salmon River and Lake Ontario for 3 day weekend.
Samsa... if it's a partnership we'll have a pretty good idea tonight what it will do on tuesday.
I transferred 20K shares to my Roth from a reg IRA - paying taxes now on less than $40K - hoping to cash out a million $ tax free within 5 years!!!
remember
20K shares today makes you a millionaire in 3 to 5 years!!!
I feel pretty safe in that it's going to be good news - there is always a hint in the stock that someone knows something - look at that positive action in the stock price before the halt.
for me... what would work well is $12 up front and contingencies for an additional $35 for the course of the next 5 years
Get my pie now... with ice cream on top.
I can't express how a nice sum right now would fullfill my life.
This has interrupted my packing for my Salmon Fishing weekend... but I can forgive it if it's what I'm hoping for.
$40 million on filing - $50 million on approval
he was suspended along with Doog
I'm upping my bid on those 100 call options to 75 cents... I think I just got a better ladder!!!
We're all excited in a positive way - we're assuming good news - I sure hope so or it's going to break my heart.
I think if Isa crashed the Lamborghini they would have not halted the stock.
It feels like Della Penna is giving the shorts the finger!!!
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=125630524
I'm hoping for a healthy partnership - with a $40+ million up front payment!!!
BUONA FORTUNA TUTTI QUANTI
Due to that pretty substantial article on Alpha... 1557 new sets of eyes are looking over IPCI now and I can see that possibly 10% - or 150 will/may take a position within the next week or so... I'm sure they are perusing it now.
Biotech Research Group (1,554 followers)
I think there are quite a few new investors looking IPCI over right now... and we will probably acquire some new investors in the next few days.
Are you all loaded up???
with a substantial upfront on Rexista they could have enough funding to take Regabatin through Phase 3
An open invitation to make 100% on your money.
Creating a win win situation with someone less risk tolerant than I am.
1. Buy 10,000 shares of IPCI at "say" 2.20 - should get a chance at that today. - layout = $22,000.00
2. Sell 100 April 2017 $2.50 call options (to me) at the now offered 55 cents each - intake = $5,500.00 so your total layout is = $16,500.00 making your net cost per share = $1.65
p.s. that offer of 55 cents is mine and I think it's quite generous!
So your break even is $1.65 - IPCI can go down to $1.65 and you'll not have lost anything.
If IPCI stays where it is by April 21 2017 you will have made 55 cents so your profit on your 1.65 investment is 33% for ~ 6 months, or 66% per year.
Your maximum profit is capped at IPCI going to >= $2.50 in which case you'll make 85 cents ($2.50 paid you less $1.65 your cost = 85 cents) which is ~ 52% for 6 months or over 100% per year.
FYI my break even is $3.05, my 100% yearly gain is if/when IPCI hits ~ $3.35 and there is no maxing out on my profit above $3.35 - so you get the low hanging fruit, which is fairly safe picking... I get a chance at possibly way more fruit... if I don't fall off the ladder!!!
Any takers???
Commented on the Alpha article.
Very nice article, however, no mention of IPCI's Regabatin development, which is a once a day controlled release Pregabalin indication to go up against... and in my opinion dominate... the $4 billion and growing pfizer Lyrica franchise when it expires in 2018.
The Governor’s Heroin Task Force issued a recommendation earlier this year to make medications using abuse deterrent technology more readily accessible. The Assembly voted in favor of the new legislation 142-0 and the Senate passed it 57-1.
I don't think necessarily shorts... MM probably filled a lot of orders yesterday from their chest... and probably replenished it today... It's all a guess of course... we'll never know for sure... like looking over a lake and guessing where the fish are.
What we need is a healthy partnership... that will change everything... no reason this should not have a market cap at least as high as Egalet.