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if the company intends to roll out Enhanced Rexista as a separate drug down the road which would require all the phase 1 and HAL studies and BE etc. which would be stupid when they could have just filed a Supplement.
Great DD Fabius!!!
I just want to clarify Net Sales so it's clear as to why it's different than Gross Sales.
You've probably seen commercials where at the end of it they say that if you can't afford the cost... get in touch with them, or perhaps when the doctor gives you a prescription they also give you a coupon or voucher that allows you a certain amount off the prescription price.
Net Sales = the Selling Price Minus the Coupon Value, so a prescription cost of $100.00 that has a voucher for $30.00 has a Net Sales of $70.00, which is what royalties are paid on.
will they file the NDA knowing they cant meet that obligation of naming the manufacturer because they haven't inked a deal?
Long IPCI- as all things do your own due diligence, buy on facts not emotions, ensure nothing fundamentally changes with the company, and sit back and relax knowing you made a sound choice and good things take time.
As you can see from this level 2 image - you only see the highest bid or lowest ask of each of the MM.
Underneath that ARCA 1.79 bid for 600 shares could be an order for thousands of shares at 1.79 - similarly an order to sell 100K shares could be lurking under those 100 shares at 1.80 ask on NSDQ.
the MM have Level 3 and see ALL the bids and asks at all prices.
At one time I could see all the NSDQ bids and asks but not anymore... I think it was just a glitch in the programming that allowed me to see Level 3 on NSDQ board.
help with images please - I assume you need a storage place where you can download images to be able to post them here... anyone recommend a FREE storage place to transfer pictures to???
do you recall how the Focalin XR approvals were handled???
Were Mylan and the other non first filers given tentative approval on their submissions at the same time Teva and IPCI were given full approval on their fist to file submissions???
Since IPCI is not one of the first filers, my guess is they do not get approval in first round
then you have two choices. file as a new drug starting from square 1 or file an amendment to your previously approved drug and jump directly to phase 3 testing. which do you think a company would do? if you choose go directly to phase 3 then continue.
I'm also not sure they would not need to start with a phase 1 study, as that is the phase which primarily focuses on safety... after all IPCI claims that they can give a lethal dose of the drug without affecting the patient... you don't prove that in phase 3... you prove it, and very slowly and carefully, in phase 1 where you dose 1 person, wait to see results... dose 2 people, wait to see results... dose 4 people etc. etc... luckily, unlike cancer, we don't need to wait months or years to see results - you dose the first patient at night... and if he wakes up in the morning... you're good to go dose the next 2... LOL.
You say "some"??? how many is some, and did someone pay you $2.10 for them???, 33 cents - almost 20% - above closing price???
Whatever made you think you could/would get 20% ABOVE closing price???, that you would put a sell order there???
I don't think those 56K shares trade was an accident or a mistake... and I'm afraid it may be for a sinister purpose... we'll see how the day goes before I express anything further.
??? 56K shares traded at $2.10 at exactly 9:30:00 ???
They can't disclose any material information at the show... so if there is anything new they want to discuss at the show it will have to be PR'ed tomorrow morning.
My feeling is that nothing new will be released.
EXCELLENT FIND NASDAQ
If IPCI is not on the map by November... this meeting will do it.
Hopefully the PODRAS patent will be approved by then... with all the news on opioids and overdosing I can see IPCI's PODRAS tecnology hitting the evening news... maybe even a news expose dedicated to IPCI's technology... oh what the heck... might as well put it on 60 minutes where it belongs.
Egalet and Collegium are also presenting, so a lot of it is on Abuse Deterrence Formulations - ADFs... but IPCI's PODRAS is about the holy grail of opioids abuse.
Others presenting -
Grunenthal USA - http://www.grunenthal.us/grt-web/GRT-US-WEB_Home/TRF/en_US/136700388.jsp;jsessionid=9DF6EE41C28483A0A2407E9C1DA007CD.drp1
Braeburn - markets PROBUPHINE which is medication for opioid addiction - not an IPCI competitor - https://braeburnpharmaceuticals.com/opioid-dependence-recovery/about/
ENSYSCE Bioscience - these guys are all pre-clinical, except one phase 1 trial - yearrrrrsssss for them to catch up. - http://www.ensysce.com/pipeline-pain/
3. IPCI will file an NDA for Rexista PODDS.
4-A. IPCI will announce a partnership for Rexista PODDS with a nice up-front milestone payment and contract will/may take into consideration partnering Rexista PODDS + PODRAS, whose research is totally funded by IPCI's partner.
4-B. IPCI shareholders meet in Las Vegas for $10.00+ party.
5. IPCI will announce a Regabatin partnership with a nice up front milestone payment - partner will fund all forward research.
IPCI shareholders live happily ever-after!!!
20K shares now will make you a millionaire in 3 to 5 years.
I think you're not understanding what "fast track" is
Don't get me wrong... it's a big plus in expediting the approval of a drug... but it does not entitle you to skip any required steps in the approval process... it does however, more readily, give you availability to FDA input... and probably the greatest asset is that you can feed the FDA partial packets of information as they become available... a "rolling submission," so that when you submit the last packet of information, they may well have already reviewed all the previous packets. It expedites the approval process... but it does not eliminate any steps.
On a psychological level...
This section mandates the Agency to facilitate the development and expedite review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
Sorry Noodle, Fast track designation does not eliminate any trials and tribulations required in order to file an NDA, but it does mean the FDA will work closely with IPCI and expedite any meetings and paperwork reviews required... and most of all it cuts the PDUFA date down to 6 months rather than the customary 10 months.
I'm also not sure they would not need to start with a phase 1 study, as that is the phase which primarily focuses on safety... after all IPCI claims that they can give a lethal dose of the drug without affecting the patient... you don't prove that in phase 3... you prove it, and very slowly and carefully, in phase 1 where you dose 1 person, wait to see results... dose 2 people, wait to see results... dose 4 people etc. etc... luckily, unlike cancer, we don't need to wait months or years to see results - you dose the first patient at night... and if he wakes up in the morning... you're good to go dose the next 2... LOL.
Would you be so kind as to explain it to Samsa???
Hey guys... guys....... listen to this........ It just came to me today.... while I was sitting on the toilet... and I'm going to share it with you all.
I didn't know this yesterday...... but I know it now............ and now, I also know that what I know now I didn't know yesterday!!!!
I'm going to share it with everybody here... but don't spread it around too much...... because then it may stoppppp working... I think... I'm not sure... I don't know..... but ... anyway... this is it!!!
FIRST... buy 60K shares of IPCI
SECOND... sell 20K shares of IPCI ... are you starting to get it huhhh???? huhhh????
That's right!!! you got it!!! If the price goes up... you make money on the 60K shares... AAANNNNDDDD... if the price goes down ... thadahhhhm!!!! YOU MAKE MONEY ON THE 20K SHARES - yeeessss!!!
You CAN'T LOSE!!!
NOW!!! who's in for the IPCI $10.00 Las Vegas party???
The technology and IPCI's pipeline could easily be worth $1B or about $40 a share
Looks like someone with large pockets was also watching the patent updates
Thanxs for the link Mopar
Under US law, the publication of a patent application or grant of a patent may be withheld if it would be considered detrimental to national security. Procedurally, it will be examined by an examiner with appropriate security clearance and can proceed as far as a notice of allowability. Once the secrecy order is lifted and the application declassified, a notice of allowance may be issued and the application may then proceed to grant.
The NDA filing won't do that... but the right Partnership can do that and more - I'm hoping for a $300 to $400 million total package on Rexista PODDS with further milestone quantifyers on +PODRAS
Excellent DD numbers.
Everything you say is true... what I have to go on is that the previous CFO said he "believed" they had first to file rights on one dosage... perhaps it's wishful thinking but perhaps there are things we don't know like for instance that some companies have negotiated to be able to market "before" Seroquel actually goes off patent.
I don't know, except I know what Shameze said... it would be a nice surprise... but I'm not holding my breath waiting to know for sure.
What I consider most important in the near future is PODRAS patent and Rexista and Regabatin partnerships.
will not risk on too much uncertainty
If IPCI is as good as you say, then why aren't everyone jumping in right now?
Best I would do is a small position until things looks more favorable.
http://www.wallstreet-online.de/diskussion/1207106-211-220/intellipharmaceutics-ipci-hot-stock-2015-2016#neuster_beitrag
Open that link in Google and it will ask you if you want to translate it.
Domenic called me as promised, but unfortunately I was there in the meeting. However, he has spoken on the AB and stated that they have not yet made ??the application for authorization as they want to go 100% sure that everything is correct and they are admitted as possible without any problems. He said the "NDA will be completed very soon" and that there is absolutely no need to worry. To me that seemed convincing and his voice was credible. I guess that we get the news about the NDA within 4-6 weeks. From then on, the clock is ticking (Fast Track) and there are speculations arise because partnerships. ME should we quickly run toward $ 2.50. Market value $ 52 million to date. A small increase in capital could again give (cash sufficient to November according to MD & A), if they do not announce already for a partner deal. Then probably the FDA decides in the spring about the fate of the company or the stock. If Rexista â„¢ Oxycodone is allowed Intellipharmaceutics should quickly can generate relatively 10-15% market share due to the product benefits, or about 230-345 million $ sales up mid 2018. Since everyone can calculate how then the review should be ... then there are the other ANDA, for any time can be made ??the admission. And Rexista would be a "proof of concept" for Podras what term also has huge potential (as a valuation for premature me). In short: IPCI has completely disappeared from the radar of most investors. For too long were no FDA approval for ANDA's and the IR I find not very good (all starts with the website). Exactly why arises however here an immense opportunity. And with the low free float should mE definitely put a foot in the door. Increases can be quite eruptive. M @ trix
serious investors probably won't be holding a large position until things are more certain.
Pfizer agreed to pay $81.50 a share, way above the previous offer of $58 a share by French pharmaceutical company, Sanofi
I was afraid to say it, or write it, and I was hoping it would go away... but that's what is usually done, most of the time.
What about the additional 15K options exercisable at C$2.88 ($2.16) and 75K options exercisable at C$3.25 ($2.43) expiring on November 30th 2016??? have they been extended???
The way I read it, is that a combined 5,527,880 shares expire worthless by Sept 10
Great catch ahasja
It's going to be very interesting to see how this is handled.
The way I read it, is that a combined 5,527,880 shares expire worthless by Sept 10 - a week from now - unless something major happens... because they certainly would not exercise the options and pay US$3.62 for a stock selling at half that on the open market.
And if there was a pop in the stock price... where are the Odidi's going to get $20,010,925.60 to pay for the shares.
Although the shares could have been specified that say the stock price is $5.00, then 5,527,880 x $5.00 per share = $27,639,400 total value of shares MINUS $20,010,925.60 cost of optioned shares = $7,628,474.40 OWED to the Odidis DIVIDED by $3.62 = 2,107,313 shares which would be issued to the Odidis, and the rest surrendered as payment for the whole amount... but I believe that it would require that the options were written up as such.
I have warrants from a private placement I did, that state that I can exercise the warrants and request that the difference between the stock price and the strike price be issued in shares - so there is no outlay of capital on my part.
Anyway it will be interesting to see how this is handled.
Also... an additional 15K options exercisable at C$2.88 and 75K options exercisable at C$3.25 expire on November 30th 2016
Close
IPCI = -1.68%
COLL = -7.34%
EGLT = -5.90%
Update
IPCI = -3.35%
COLL = -6.56%
EGLT = -6.58%
For those who might think IPCI is selling off today... just want to point out that IPCI is right now down 3.35% while Eagalet is down 3.98% and Collegium is down 4.34%.
What you are seeing is the selling by those "traders" who bought with the intentions of selling the news for a quick profit.
My guess is that not a single IPCI "investor" has sold a single share today.
Mixing an emotional attachment to a company is never a good idea.
It makes sense to hold both short and long positions here.
It would certainly clarify the statement "turning good news into bad news" and the boiler plate warning of "not knowing if screening will resume", no need for screening to resume if FDA grants approval based on submitted data.
it wouldnt surprise me if we get 1 PR which states both. that they filed and entered into a partnership at the same time.
I really don't know what you're not understanding.
I hope you agree another round of share offering and thereby another dilution is on his way
It is just common Sense
My guess: much Lower then $1,61.