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Hasn't this type of crap been going on for a long time? Wonder who is behind it or is that just a stupid question?
Weezuhl- Riddle me this... Why is ELTP trading at $0.14? What have they done to correct their CRL? And why do you think ELTP is such a great company while IPCI is such a dog?
Pharmer guy = Tony pros son, Tony pro = pill popper...
Impacttrader is probably Weezuhl as he now is short...
Yeah Doog- This weezuhl guy just keeps coming up with something new to beat up on them for. PH3 will be required, NDA will never be submitted, etc., etc. Now it is whatever is next down the line... He is no doubt part of the group of people that shorted at $3.
But Weezuhl... The blue dye has been a known part of Rexista for a long period of time. This will not be news to the FDA as I am sure it was part of the original discussions the company had with them at the IND stage.
wimike- Great link! And if you look back, you can see that IPCI has been working this path for a while. The big take away here is since the NDA is now accepted, we are very, very likely not be required to do a PH3 study. That alone saves the company millions of dollars!
Weezuhl- Wasn't it you who said that since ELTP had to do a PH3 IPCI would eventually have to do a PH3 on Rexista? Looks like no PH3 is likely required so now you move on to the next thing to bash...
Angelo- I do not think it is out if the question for Focalin sales to hit $8M for IPCI in 2017. I also think that when PAR gets all doses on the market, and there is competition in all doses, we can still expect over $4M of revenue annually for Focalin sales.
Fabius- To be honest I take the revenue numbers that are shown on this board by various posters more seriously than the "professionals" covering it. Those "professionals" have been wrong time and time again on estimates and price targets. Don't forget that. So if you really want the best revenue projections, look no further than this board. Here are my updated estimates:
Focalin 2017 $6-8M
Seroquel 2017 $2-10M
I do think my Focalin numbers will be very close. But Seroquel is a tough call, thus the very wide range.
In regards to Rexista, we just don't know and will have to see how this situation develops. I am confident that they submitted a very good application and at this point we just need to wait and see how everything works out.
I do think there will be more ANDA approvals in 2017. I am hoping that at least one of the other partnered ANDAs is approved. I do think that is very possible.
Tekterra- Don't forget... PAR already launched the two Focalin doses that have exclusivity. That 180 days of revenue will be a big chunk of 2017 revenues. Yes other dose launch dates TBD but you can be certain PAR will get to launching those soon.
Amigo Mike- If you have a lot of questions, I recommend you contact IPCI directly. I am guessing they will try to answer any questions you have as long as it is not confidential information. My take on analysts like Mackie is this... They write what serves them best. Whether it is true or not is another story. I suggest you ask IPCI directly what their expectation is on Seroquel launch. From everything I have seen/read, they are doing their best to meet the May launch date. But I am guessing they won't 100% commit to this. And that is the likely reason Mackie is putting this launch date in question. Like I said, if you have questions contact IPCI IR.
Samsa- Agreed if FDA approves another ANDA already partnered with MNK great things happen... Shorts will have to cover as they won't be able to hold this below $3 because that next ANDA is the tipping point on profitability!
One thing for certain, is that revenue for IPCI in 2017 will be on the upswing. I think they do have a chance to break even or perhaps show a small profit. Profit will be dependent on development expenses, etc. Another ANDA approval- especially for one already partnered- would really help out. It is going to be a good year for IPCI!
Doog- I was the one posting that 4th quarter earnings could be good. I was expecting the $3m to be included and not amortized.
Sprot- The crazy price movements are not so much driven by the fundamentals of the company but more by the work of the traders who move the price to suit their needs. No?
Tek- I agree. Not bad at all. Patience is required but revenues are looking on the upswing for 2017... The traders will do anything to twist the facts to meet their agenda of the day.
Samsa- Don't miss out on the fact that the $3M from MNK was accounted for as deferred revenue. So the total cash that came in during the 4th quarter in reality was substantially larger than the actual revenue statistic that was reported.
I had a chance to quickly read through the report. People that just look at the loss statistic are really missing the details:
1. The $3M payment form MNK was reported as deferred revenue and only partially recognized:
Deferred revenue represents the funds received from clients, for which the revenues have not yet been earned, as the milestones have not been achieved, or in the case of upfront fees for drug development, where the work remains to be completed. During the year ended November 30, 2016, the Company received a non-refundable up-front payment of $3,000,000 from Mallinckrodt pursuant to the Mallinckrodt agreement, and initially recorded it as deferred revenue, as it did not meet the criteria for recognition. As of November 30, 2016, the Company recognized $37,500 of revenue based on a straight-line basis over the expected term of the Mallinckrodt agreement of 10 years. In 2015, the Company received an up-front payment of $150,000 from Teva which it continues to record as deferred revenue as the criteria for revenue recognition have not been met.
2. The accounting mumbo jumbo reported by Cysonic is important to recognize as well.
I think everyone needs to keep in mind the positives as well:
1. They are sounding positive on Focalin and Seroquel revenues. This is big news and the type that keeps giving quarter after quarter after quarter...
2. They are looking to step up development. Yes this costs money, but the science/scientists are the future of the company. Great developments can pay big year after year after year... Penny pinching can only hamper development. And if they need to sell a few shares to get PODRAS and Regabatin moving then so be it.
Thank you Samsa. I am glad most people understand what was trying to be conveyed.
Weezuhl- You are twisting what I said. The only thing that was conveyed was that there was misinformation and confusion on the boards regarding the manufacturer being listed on the application. IPCI's position is that that they do not need to specify the manufacturer. If Rexista were to be approved with no manufacturer listed on the NDA, a tentative approval would be granted. Not a rejection as was theorized here. They in no way shape or form suggested that their plan was to go to decision date without naming a manufacturer. But they did not suggest they would name one either. I hope this helps clear up any confusion people have on the subject.
Samsa- I am thinking earnings report will be a positive one. Will that move the stock? Who knows... An ANDA approval that is already partnered with MNK would be seen as appositive thing revenue wise. I am guessing that would be a nice catalyst in the near term.
I received clarification from IPCI in regards to specifying the manufacturer on Rexista NDA. Their position is they do not need to list a manufacturer to receive tentative approval. However, to receive final approval they need to specify the manufacturer. I hope everyone can put this issue to rest now.
All- Regarding the ANDAs... Some are likely to be approved this year. All of them will not be, but I am guessing a couple more fall in 2017.
Samsa- Remember some of these ANDAs may have had correspondence. I think 90% meant the ANDAs would be reviewed. There is no guarantee of approval and they might be taking longer because of back and for the between FDA and IPCI.
Fabius- Remember the FDA may have responded to IPCI on a number of these ANDAs and asked for more information/clarification/tests/etc. I am guessing a number of these have had correspondence. There is no guarantee that all ANDAs will be approved in a certain timeframeif the FDA finds issues with the application. Lastly, remember issues with applications are not uncommon and can be remedied. It just takes time.
Doog- Agreed. lotta coulda, woulda, shouldas from the nervous nellies... Come on people... You are either in or out. You either believe in the company or not!
Well good luck to you as well as all other IPCI longs. I think this could be the turnaround year as far as revenue.
CIronman- The only thing that will move this now is revenue. Patience... The near future will show additional revenue in the following:
1. Additional Focalin XR doses coming to market
2. Launch of Seroquel XR
3. Cost recovery payments from MNK for commercialization of the partnered ANDAs
4. Partnership for Rexista
5. Additional ANDA approvals that are partnered and commercialized.
2017 should be the first year IPCI gets out of the red. The future has never looked better for IPCI and I recommend hanging on for a little while longer.
TriumphTR8- This guy has been lying to everyone on here for a while. Many people have called him out... He is now busted and will no doubt just create a new identity. Thanks for contacting IR and proving this guy to be the liar everyone thought he was.
Sparky- That was what I was thinking too!
Samsa- Correct, the only thing that will move this thing is money.
Ray- With what you describe I would consider you a long as well. There are other flippers around that are trading this thing more than they do their laundry.
Ray- There is no bad news. I thought in one of your more recent posts you said you just bought. I might be mistaken but I took that as you were flipping.
Tek- My main problem with swing traders is they are pumpers and dumpers and you cannot trust what they say. IPCI has developed a reputation for not holding gains. I think that is partly due to these traders.
Angelo- I agree... PH3 issue is put to rest. Yes, the FDA can come back and require more testing, but if there was some glaring reason they felt a PH3 was needed, they most likely would have said it prior to NDA acceptance.
Garden Rose- I would say disgruntled swingtraders fits the bill exactly... I said we would hit $3-4 on this announcement and we would hopefully hold $3. Those were my expectations. A partner announcement with money may help us break to a new level. If IPCI could shake some of the swingtraders it would be a great benefit.
Rayank- Too many sellers... Short and swing traders. Did you sell? Were you planning on selling? Are you disappointed that today was not an easy 10-20% swing trade profit for you? Or are you disappointed because you are an IPCI long and there has been some bad news in regards to the company? As far as I am concerned, things for IPCI as a company have never looked better. As far as IPCI for swing traders... It is getting harder isn't it? Too many cooks in the kitchen and getting harder for these small time players.
Amigo Mike- Consider this... Maybe the formula of PODRAS has been tested in humans. However, it has only been tested at normal dosage and not under overdose conditions. That would verify it is safe for use when used as directed. I am just wondering how you test a drug with overdose deterrent features??? Has this been done before or is this something 100% new to the FDA?
wimike- That all sounds good! You are right, big buys always are followed by PRs.