Fred...great and thank you. I will chime on this one. Angelo's estimates were pretty close. he estimated 460k for the week of 9/22 and they came in at 453k.

for the entire 2QE sales we hit 1,442.36K. For just the 4 weeks in September alone we hit 1,616.52. at that rate, we should easily hit 3 to 3.5mill conservatively in 4QE with Seroquel.

Now the question remains, those numbers above are sales NOT profit. just what is the profit margin as well as the profit split on those numbers?

Still headed in the right direction! Thanks again Fred. This provides good insight.

Mopar. No offense taken LOL

doog. Just checking in and catching up on posts. I personally do not see him creating divisiveness as much as trying to show what he feels are more reasonable expectations.

Remember a few months back I was screaming at the top of lungs about how the manipulation has hurt this stock? that we were trading at $2.50, down from the high of around $3 when announced Rexista filing and there was absolutely no justification for it. That based just on Revenue alone we should be above $3 and I was bringing up forward P/E then.

Just about everyone was telling me how wrong I was. that the generics are not a valuable. that the money is in Rexista. Now we see that that stalled for lets say at least 1 year, as we know it will take about that long to do the studies and settle the litigation and then finally resubmit and get a tentative approval, so that time frame is minimal 1 year.

Now all of a sudden everyone is grasping on the revenue to shoot this back up. so, one has to wonder why the change? clearly, we are way undervalued. I felt we were under valued back before adcomm. BUT, I had been here through the Focalin approval and after that first QE we had income of around 2 million and everyone, expected more of the same because we had exclusivity, and what happened? we didn't meet near that and the price tanked again.

what happens when everyone is expecting us to make that Penny as the analyst predict and we end up loosing say 10 cent because of increased spending due to litigation costs and now additional studies? while I would be saying look our revenue increased 100% from last quarter, the manipulators who have been controlling the stock this entire time will drop it back to levels who knows where.

so, I think Wim is just being cautiously optimistic here. he sees the sales as being reported and the revenue. while its increasing exponentially the weeks in question for this 3QE report we not stellar as they had a slow startup. how will that effect the projected earnings? its difficult to say.

Honestly, I think its his way of hoping for the best but prepare for the worse as we know what the manipulators will do if given the chance.

anyway, good dialogue guys. and really helpful Fred with the numbers! will check back soon. I got to keep a low profile for now.

Your are correct Angelo. They are clueless. All will be revealed before too long. LOL and for the record, I have not gone to the dark side. but I can not go into details at this point.

Angelo. Honestly, they just needed to PR that when they intend to do the next series of test for Rexista they have enough cash on had through revenue stream and do not need do another offering. It is ridiculous! Do they not even realize the current lawsuits against them are gauged by the average sale of the stock price 90 days after the downward spike? Oh well, let the slide continue! If they were concerned about the litigation all they needed to do was was prop up the share price.

Excellent spread sheet Angelo ! and many thanks for the numbers Fred!

Fabius....actually I was giving him an A for trying to get me to talk about what is going on. LOL

Angelo....LOL I will give you an "A" for effort. All will be exposed in good time.

Doog.....I have still been here reading and watching in silence which I am not at liberty to discuss at this time. Now you understand the pain. It has never been that someone such as myself did not believe in the technology but, was always amazed about the manipulation that has taken on and how we go down on bad news and no recovery of price on good news.

anyway, I agree and have said it numerous times, the double edge sword here was having the lead scientist as also the one in control. that they tend to make bad business decisions because they try and protect their baby. I had also previously said, the company is being run like a private company rather than a public one. It appears your comments now agree.

May I suggest, then take an active role and do something about it! I know I have. In the end this is a public company. If you take the time, you will be able to find the corporate bylaws and see that the Board of Directors is responsible to assess the performance and compensation of the main officers, ie the CEO and COO. They also have the right to call for emergency meetings. They also have a direct email on the IPCI website.

so, maybe its time to hold some of them accountable to do their job as well? Just throwing out some "private thoughts" LOL

No...I am still here. Just under a gag order for now.

Dig....I do remember you from yahoo. we had some some good discussions. sometimes we agreed other times we didn't LOL. I think you are mistaken here in one aspect. I do not think this is a phase 3 requirement. I think there is a diffeence between the costly phase 3 you are thinking about and we got a waiver on and the category 3 HAP tests we are now going to be doing. These should be rather inexpensive. they may be time consuming but should be in the neighborhood of 1.5 to 2 million each. add into that, another 1.6 million for filing fee, assuming we get a CRL and need to refile. we may be looking at 5 million total. its very possible we could do that with existing cash flow.

Doog.....good points. but what if he doesn't? I think that is the fear right now. Odidi not wanting to give up control or be able to admit his bungled this and be willing to bring in the needed help?

Personally, I do not like the fact Penna is leaving. I felt he had a good grasp on things and was very knowledgeable. my fear is he is leaving because Odidi still thinks he knows best and is treating this like his private company rather than a public entity.

uncertain times for sure. no real answers

Beachguy.....Im not sure I agree with your sentiment there. Personally I think Penna was the level head. I really think the problem is Odidi. he is a one man show. he keeps his wife as COO. why? what makes her qualified? Its so he can control that office as well. I personally think Penna put up with Odidi and his ways but now because he is personally drug into the lawsuits, I think he has said he has had enough. Odidi does not see the damage he is doing by trying to be a one man show. one man can not do everything efficiently. It is really starting to become unnerving. you can not complain about the science, but the way he is running the company is highly suspect and getting worse daily. why haven't we had deals for Glucho and Keppra? does he want too much money? does he not have the time to making the appropriate contacts? they said Regabatin is sheved until they partner it. thats been what a year now? why hasn't it been partnered? no time to work on finding a partner if he has been too busy trying to get ready for Adcomm. who knows, they are tight lipped and not giving much direction. I realize they are probably waiting for FDA to get with them so they can determine just how to proceed, but the silence is deafening and now when they did make announcement it was to tell us Penna just is up and quitting. This is not what we needed right now.

Fabius.....I sure hope you are wrong about the next 50% free fall. I know, the chance for a tentative approval is slim in September, but my god, another free fall? I would think its already priced in for total failure. We are at 2008 price levels already. I can not imagine we see another free fall on that news. I would think it's already priced in. well, I would hope it is already priced in.

Numbers....you make a valid argument. I can not disagree with any statement you made. The only thing that does not make sense then is,the FDA's acceptance of the application and classifying it as substantially complete. One would have thought they had communication with the FDA all through the process and the FDA gave guidance as to what they would expect. Which tends to make one think the FDA was ok with going with 1 route of abuse labeling now and then following that up with the others.

BUT, just like Remoxy, did they not get direction from the FDA prior as well? IT makes me wonder if the FDA goes down one oath, telling the companies one thing. Then when the rubber hits the pavement and someone else gets the application they have a different opinion and then different direction? I really can't tell here.

As a side note,a question regarding a CRL. if one is given, is that like a denial and the company must resubmit the application all over again as if its new? if so that would be an extra added expense as we only qualify for the waiver one time. If we have to submit a new application we would not be entitled to the waiver. That would add an extra 1.7 million to our estimates on top of costs of studies.

Lex.....that's subjective. LOL....There use to be a time we were complaining about the price hanging at $2. now we would be looking to sell if it hit $2. how times have changed.

Doog...I agree. I am beginning to wonder if the lack of institutional investment is due to the current corporate structure? the fact we have one man as a co-CSO as well as the CEO and then has his wife as COO which we all know is a placeholder for him to act as COO as well. When one man tries to do it all, he leaves something else sit while concentrating at the immediate task.

Regabatin has been shelved for some time now. they said, its shelved until they find a partner to further the studies. my guess is, its shelved and hes not working on securing a partner because he was too busy preparing for the Rexista Adcomm. Large investors are probably scared off or hesitant to invest with that kind of mentality.

I really do believe if IPCI is to continue to grow he needs to recognize, a good leader does not need to know it and do it all but knows how to surround himself with people who do. If IPCI is to continue to grow, he needs to loosen that death grip and bring in the talent he needs. The best way to handle this would be to partner Rexista now and be able to tap the resources of a big pharma who then would be working with you.

we will see in the next few weeks how things transpire. we are at a cross roads. Hopefully he learns from his legal team fighting Purdue. they recently, added 2 more lawyers to the team strictly to deal with discovery. Everyone needs help at some point and there is no shame to it, its the wise thing to do.

Fabius....I agree on both points. If IPCI was following the FDA's guidance,they would have a great case for "Detrimental Reliance" however, would IPCI start fighting for themselves? we didn't see them sue the FDA when they screwed up Focalin. Compound that with the company putting out a PR immediately after Adcomm saying they would do the tests, also indicated they have no intention of fighting for themselves but just rolling over and now saying, they will do the tests. I do believe, they could use all this to their advantage to at least secure a tentative approval. Assuming they have the negotiation skills. They could argue; "since we are doing what the adcomm recommended,and since we are stalled waiting on news from the legal front as well as lack of US manufacturer, grant us the tentative approval with those conditions". Will they? that's the question.

which brings me to point 2, not only is this a good time to bring in the partner for the money to complete the tests, it would also bring in the help that is clearly needed. With the scientific data on the IV abuse deterrence superiority, and the panel, still not voting for it, clearly, they need help. The data doesn't sell itself. they need help with dealing with the FDA. bringing in a Partner could get them the help they need.

Beachguy.....difficult to say. Each judge is different and most times there is an agreed too amount of requests such as this that each party has determined they would accept.

The latest from the Purdue litigation for those who are interested. looks like they are trying to stall and not want to reply to discovery requests. make your own judgements as to why they would do this LOL;

That's an understatement. we never had any value attributed to Rexista as it was but they used any excuse to drive it to all time lows. I have been an owner since 2012 and never saw it this low, and that was before we had any revenue stream. unfortunately, until the FDA gives the company more guidance as to what they expect going forward, I feel we are in for lower lows. Its going to be a rough ride.

Fred.....I have nothing to add. you pretty much have a good handle on it and summarized pretty well. The current sh*t fest we are in.

Angelo....I like your "out of the box" thinking. I have no idea as to the legalities of stock flipping by the company. There may be a regulation out there such as there are for individuals and it may violate wash trading rules if they buy up their own shares and then resell within a certain time frame.

That being said, while that would alleviate the immediate need for cash for the studies, it would then cut them back on their operating expenses. they need the income from Focalin as well as Seroquel for cash flow positive and to cover normal operating expenses.

I still think these tests may not be as expensive as we think. maybe 1.5 to 2.5 million and could possibly be completed using the current revenue stream. My fear is, they still need to sell maybe a few hundred thousand ATM to bridge the gap and that will just put continued downward pressure on the stock.

They really could use another ANDA approved right now that is already partnered OR they could find a buyer for Glucho and Keppra. that's under utilized value right now! Its just sitting there. at this point give it away. for 4 million just outright sell the both if they had too. they do have options other than the easy way and depress the stock further.

Mopar...I believe you outlined exactly what the holdup is. the company immediately said they intend to conduct the studies, however, they only have protocol set for intra-nasal study. My guess is they still need a protocol set for the Oral route of abuse.

That would explain why the company needs further direction from the FDA. they can commence the 1 study now but the other one needs setup. That could give us a slight delay on our timelines.

mentalist.....well, thank you for that observation. LOL. I do not hold the same gloom and doom. they did have a set back on Rexista, but I surly do not see it as dead.

in my opinion its a matter of submitting the additional test data and how they pay for it. I actually think its a possibility they could even get a tentative approval in September. Slim, but I could see it. the best the company could achieve was a tentative approval anyway. they don't have a US manufacturing site named. so to avoid any issues of litigation, because we all know IPCI was probably following their advice based on the meetings and IND etc., that they could tentatively approve and set conditions of the company submitting positive category 3 tests for oral and nasal and naming a US site.

while there may be political backlash from that, I could see they then have the argument they addressed the adcomn concerns. at which point they do the tests in 6 months, name a partner within 6 months and probably have a resolution in the litigation all within the same time frame.

so, you can keep your gloom and doom, your entitled to it, I think this was a set back and only that

wim...I was just going to say the same thing. That was great DD doog! that is why I say at this point is a toss up. In my heart I feel they should tentatively approve just for the reason you mentioned, especially if the company is following it up with immediate other testing. Its just an unknown at this point.

I will say anyone who took time to read the dossier the FDA submitted, the FDA themselves were pointing out the overall superiority for Rexista. which is why I was shocked, that the FDA allowed the adcomm to go off target so much.

but that is exactly why I have not sold a single share. I still have hope. there is no doubt in the technology !

Doog....I totally agree with your observations. those questions the panel raised were ridiculous and irrelevant. However, as a litigator, I know the responsibility was then on IPCI to defend and actually attack those statements. That panelist raised the question of the tests being done in Jordan as an innuendo that we use 3rd world countries for guinea pigs. The presenter should have been a pharmaceutical lawyer instead of a toxicologist. The adcomm should have been looked at as a trial. I would have answered that question with an attack such as " why are you even questioning where the study was conducted? I do not understand? it was conducted at an approved FDA site could you explain yourself?" and place them on the defensive. Hence why I say, while the Adcomm totally messed things up and got off track, and did not focus on the issues they were there to focus on, it was IPCI's job to get them on point and sell the data.

That being said, Im still on the fence. the FDA surly knows the cluster that panel was. so, there is a possibility they could still grant a tentative approval and word it in such a manner that the company submits successful completion of HAP studies. HOWEVER, that is a political bomb that I doubt in the current environment they will want to undertake. I can just see the liberal media now "FDA approves Opioid drug, even thought Adcomm panel overwhelmingly says is unsafe" That would be the misleading headline.

so, Im not holding my breath, this will be a toss up. if there was anytime the FDA should discount the adcomm it would be in this case but I just do not know. I think the real issue now is what guidance they give the company and then the company give us the costs estimates and time frame of completion. which hopefully that information will be announced this month. I am sure the company is waiting on official communication from the FDA at this point.

Has anyone else noticed. when a stock POPs on good news. it always retreats and we are told it needs to fill the gap. I wonder why it doesn't work that way on the way down?

where is that filling of the gap now? LOL Its like I have said time after time. My biggest complaint was no value was ever built into the stock for Rexista. we were trading at a forward PE of 2.7 with just the revenue of the Generic pipeline.

But let there be a setback on Rexista we are taken to levels that have never seen since I bought in back in 2012. WTF ????? Was the ADcomm a total cluster? absolutely! a lot of blame to go around. BUT when looking where we need to be, logic dictates it could just be a 6 month setback and our current revenue stream may be able to pay for it. so the worse outcome then is, it takes us another 6 months to become cash flow positive.

if thats the case, we are way undervalued.....until the company gives us the needed updates as to exactly what will be required and how much it costs, I am just riding this nasty wave. Personally I think we fell too far too fast.

but hey, Its not like I can control the price action.

Angelo....hey now, watch that comment on the blood sucking lawyers LOL. not all of us are.

Here is my take. I am currently holding. I own 110,000 shares and haven't sold a one yet.

Issues as I see them;
1. We have no clue how much or how long the additional testing will take. therefore, it leaves us in dark in regards as to still being cash flow positive. The company may still be able to cover the cost of the additional tests with the increased revenue however that will increase expenses and therefore we still show a loss for the upcoming quarters. without knowing the lenght of time to conduct the studies we can't assess how long it could effect us becoming profitable. so IMO, being cash flow positive is now in question even though we know, their revenue stream is improving.

2.Adcomm was a complete cluster. even with the superior IV results, the panel was so confused with the data that they still voted against even the IV abuse deterrence. This is an IPCI problem not being able to sell themselves. therefore, without a change in administration, I do not see not that changing. They need to bring in someone with the experience to sell and communicate the superior data. To me, this would then suggest the best possible time to bring in the partner. let the partner help with this.

3. Needing to raise cash for tests is either coming from 3 avenues. A further dilution, which could be the ATM shares or may be the need for additional offering like last year. B. the current Revenue stream picking up may be able to cover the cost C. If they partner now that would give them them the needed revenue. as well as bring in the extra help they seem to need to work with the FDA.

4. while the one lawsuit that has been named regarding the violations of 10B and 20A has been filed I find they will not go anywhere as it is going to be difficult to show anyone on the board had anything to do with wash trading or share price fixing on insider information. However, there is a cost involved with defending. Another lawsuit of a different nature , if filed, would be more successful. that would be a section 18 violation. I feel if that kind of lawsuit were filed it would have merit however, most of these are settled with the insurance carrier. one thing we do not know is the specifics in the Policy.

so, in my opinion when looking over the above issues as I see them , right now its to premature to accurately predict much one way or the other. I think the company needs to get more direction from the FDA as to what they now want. that will then give the company enough information they can determine as to how to fund it and be able to tell us how long to complete. so without all the information, I am not adding to my holdings at these levels as we may be headed lower. However, I am not selling as they could after looking at the options decide to partner now and this entire "sheet" feast just turned around.

so I am patiently waiting for additional information.

Derek....Under normal circumstances I would agree. Even though the vote did not reflect it, the IV abuse is superior according to the test results and the FDA's own analysis. You are correct in that, the blue dye being used is within FDA generally accepted amounts and therefore should not even be require to do the study.

However,under the current Political environment in DC I would be very surprised if the FDA gave a tentative approval. They should and I think IPCI could put pressure in them to do so. However, Just think of the political outcry from the media if the FDA tentatively approves an opioid that failed miserably with its Adcomm and will be touted in the media as not having proven safe because of lack of safety studies?

we all know how the media is finding any negative issue they can to hammer the new Trump administration. could you imagine the media coverage on this one? just like the hearing itself where the data clearly showed superiority, the panel still voted 19-4 saying its not IV abuse deterrent because 20% of the Oxy can be syringed at 30 seconds. That is what will make the headline. not the rest of the slide which showed Oxy itself can extract 40% at the same time frame.

I hope I am wrong but as much as Opioids are in the news daily, I just don't see it happening.

Doog......Your comments are accurate.

That is the exact route Purdue took and received approval. The problem was, It was IPCI's case to present. as soon as the panel started questioning these issues why didn't they just raise it and bring to the panels attention? One panelist stated why are we going to deviate from past practice now and then with an opioid. That would have been the time for IPCI to state that fact.

The facts are the facts in any case, criminal or civil. Its the job of the lawyer to present those facts in a convincing manner so your client wins. Even with overwhelming evidence of IV abuse superiority,the panel still voted to deny they met that! Either the panel was influenced by someone OR the case was presented very very poorly. If a lawyer presented a case such as that the client would ask for a new trial based on ineffective counsel and probably sue the lawyer.

Honestly, If I were IPCI, I would be arguing with the FDA tooth and nail going forward stating these exact facts and saying we relied on past practice, your guidance, etc etc to still and try and gain a tentative approval. However, in todays environment, I think it is unlikely that the FDA goes against a 23-0 no vote to then approve an opioid. That would start a huge public outcry and political hot potato. But it would not stop me from taking that position that they need too.

IPCI needs to partner this now and bring in the right people to sell this product to the FDA. Clearly, they do not know what is needed or how to handle things at this level. Nor are they prepared on how to answer politically sensitive questions. when questioned about the mental consequences fo turning someone blue, they were not prepared to even stand up and fight for their position and say, it may. however, the intent is to give doctors a extra tool to detect abuse. No drug, even Chemotherapy has a side effect but the benefit outweighs the risk. but they never said that they stood there silent. OR they should have just said any talk about it is irrelevant as we are here to only talk about IV abuse! either would have been better than what happened. At this point we know they need extra money as well as more experience. I would rather bring in an Novartis or MNK, who have the influence and knowledge. They need a partner anyway. why dilute shareholders, when they could partner now and get the extra help they clearly need.

after all this I still say the price action is BS. there was never any value built into Rexista to begin with. That is the extra kicker here. we popped up to $3 on news of application and lost that value down to $2 within the next few months. just the Generics should have had us higher in value. At least we could have absorbed this shocker. Its a sad day when I say I would be happy to see $2 again!

our only hope is that they partner this. if he dilutes at these values it will take us off the NASDAQ right into the pink sheets.

Fred. ..well then thats the issue...There is a discrepancy here somewhere. ..they mentioned in the meeting about doing human studies..if yiu recall the one panelist was concerned them being done in Jordan. The issue became as I saw it they didn't have completed the tests fir oral and nasal. The reason being that they were not going for that indication yet and could follow up later. ..I believe that will be the basis of litigation as numbers has just pointed out the pr put out by the company suggested that they were going for indication of oral and nasal. Hence the misleading of shareholders claim.

Fred. ...well then let me say I may be schooled in law but not so much in pharmaceutical lingo. .is there a difference between category 2 & 3 Tests and phase 2 and 3 tests? If so what are the differences and time lines? I took for granted they were asking for phase 3..maybe this wont take so long after all or be as expensive.
Thanks

Angelo.....I would agree, that would make sense. We can not afford to dilute at this point. besides, the lack of preparation going into adcomm clearly shows they need a big player on their side. I hope they are listening.

That or either start putting the screws to the FDA, which they didnt do last time with Focalin. while, IPCI has to accept blame for their lack of preparation. Clearly, IPCI can make a case for detrimental reliance in the event the FDA does not approve. However, with the recent PR stating they would just do the phase 3 its unlikely they would follow through with litigation.

Its 50/50 though as to that fiasco. someone had the responsibility to inform adcomm as to what the issues were and that the FDA granted the waiver and for what reasons. with it being IPCI's application I say they had the greater duty of care but clearly the FDA saw the thing was going south which is why they revised the question to vote on. which in turn just confused the panel more.

sad all the way around. lack of preparation all the way around. even the panelist seemed like they didnt read the packets given to them.

Just saw another firm joined the fray. This is not going to help us. only good thing is this is not an SEC investigation but brought on by law firms.

who knows, maybe by competition. kick them when they are down so to speak to stomp them out.

Litigation update.....there appears to be just a notation in the docket that Purdue will be submitting a revised proposed order and then agreed upon deadline. so I suspect we do not hear any rendering until that new proposal is submitted. hence the agreed too date.

The sad part is what I have said all along. No value was built into IPCI for Rexista. Now, on the bad news we will tank below where we should be trading just on the Generic pipeline and revenue.

Everyone has always traded IPCI only on Rexista. I am afraid now with having to do phase 3 studies we are a year and half back. so unless the market sees the value in the generic pipeline I see a stagnate year ahead, which is a shame as I have constantly said we were undervalued at the present just on the generics.

Yesterday, I do hope was a wake up call, Odidi is not prepared to take on the FDA by himself. he really needed someone with experience there at that hearing to take charge and get the panel back on focus. The mere fact that the blue dye BS was even allowed to continue was ridiculous and only served to deflect the attention away from what they were charged with on the IV abuse deterrence.

the mere fact, they voted the way they did on that aspect alone showed the panel was totally lost even as to the science. BUT, that then is the job of the applicant to dumb it down. Whenever, I had a technical case to present I always had the client "dumb it down" so even a child could understand. they really do need someone with experience and or a lawyer present at those meetings. a hard lesson to learn.

so lets wonder how far we crash today? honestly, as I have stated we shouldn't. No value was built in to begin with! we already lost 40 cents a share on Monday. But we all know how this is going to play out, which is why I get so disappointed that the stock does not rise and hold value on the any of the good news. oh well.

Cysonic.....do not be so quick to in your categorizations. I learned a long time ago there is a difference between being right and winning. You can win and still be wrong. the reason the blue dye issue won yesterday was because IPCI went unprepared to address it. They should have replied this is not a topic for discussion as the only thing to be considered is the IV route of abuse deterrence and if the drug is safe. we are merely adding blue dye into the compound at this point in amount already recognized as safe by the FDA. move along.

The concept of will the blue dye work as intended etc should along been brought up once the labeling request was being asked for. adding in a compound in generally accepted safe limits was issue and IPCI let it get out of hand. and they then should have argued the reason and logic behind why phase 3 was waived by the FDA. that was never addressed.

so, yes, he was correct in that the blue dye became an issue but that does not make his arguments right.