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Doog...with todays volume of 1 million shares plus what about a hostile takeover? all someone needs to do is buy up like 10 million shares and they would get control or at least outweigh the Odidi's. this is the risk of a low float stock. why pay 500 million for Rexista when they can buy 10 million shares on open market and probably just bump it to $5 and get everything?
I would not want to be short going into the evening if trading isnt resumed. LOL talk about sleepless night
probably open up where it is at 2.30. someone bought a huge stake at 1 million shares. right before it was halted. that would scream inside trading if there is buyout. in my opinion 11.50 would be too little. so unless its a hostile takeover from the person who just bought the 1 million shares
ut oh.....I got my answer...Intellipharmaceutics International Inc. (IPCI) Halted due to regulatory concern
CDNRX....did the exchange say its halting trading? NASDAQ still seems to be trading
looks like heavy volume 1.2 million shares. actually would have expected a larger pop.
yea whats up just saw price spike to 2.30?
Angelo.....its not me misleading anyone. All I am doing is pointing out what the company has publicly stated. and then also pointing out what the company can legally do if they choose. the company had 1 IND. the company put out a PR stating they HAVE ENHANCED their Rexista with PODRAS. they put out a PR that they received fast track status for PODRAS. All the nay-sayers were wondering why the company needed to do a 4th phase 1 trial hinting they were having problems. duh, its because they changed the formula and they needed to prove it was safe. The company has said they can file an NDA-S if they choose for PODRAS. Doog himself confirmed that and relayed that on this forum. just like any lawyer, I lay out the facts and then in summation I draw a conclusion. the company can add anything they want to their Rexista formula and file the NDA as long as they do all the safety trials and prove the BE. they only filed 1 IND but yet discussions with the FDA included PODRAS. they can most certainly add PODRAS to the formula and as long as they dont make any claim concerning it, they are just marketing Rexista. the same as if they just add a vitamin to the formula. once they want to make the claim that Rexista has overdose protection, they need to "prove" that statement and that can be done through the NDA-S pathway. a much shorter timeline than starting over with a new NDA. because of this the PODRAS patent becomes integral part in any discussion for partnership as well as why they need a number for filing so they can add the patent number on the application. now, if you would like to debate this, tell me what is misleading here.
Numbers.....you got it!!!! congratulations. Im not sure what people cant understand. or they are shorts and dont want to understand. the company had 1 IND. the company already has fast track status for PODRAS. hmmm I guess PODRAS was never talked about then in the IND? the company is now filing 1 NDA. it doesn't take rocket science to figure out. they already enhanced Rexista with PODRAS. go back to my original analogy of adding vitamin A to Tylenol to heal cuts. the company can absolutely do that and make that part of the formula as long as they dont claim that tylenol now cures pains and cuts. once they want to do that, they will need to file an NDA-S to change the indication. at which point comes the extra trials etc. which is why they need to wait till they get a patent number for PODRAS because they have to name all patents that their formula is based off of. they can add candy cane to formula of Rexista if they want. all they needed to do, which they di by the 4th phase 1 trail was show that the formula as submitted is BE to OXY. the claim it also has overdose capabilities comes later. NOW they also have the ability NOT to include it and go off the 3rd phase 1 trail if they wanted. that is where the negotiations comes in with any partner. do they want to be part of PODRAS or not? Im thinking they would. but hey, if anyone feels like weezhal that PODRAS is just fantasy. so be it. but one thing I can tell you the company will not tell anyone what the exact formula is for Rexista. Thats company confidential as it should be. your only going to be able to find that out after the fact when you read the NDA which will lay out what patents they are going off of such as the Oxy patents etc and you happen to see the new one slide in or also when they announce the partner and they disclosure terms because like I keep saying , yes once they want to label the PODRAS they will need to additional trials.
I agree....they have a lot planned and the catalyst will be having the approved patent in hand. then the only thing holding them back will be funds. honestly, if I were to guess I see the big PR we are all waiting for to be two pronged. 1. announcing the filing and 2 right away announcing a partner. Just my feeling that they will not wait on inking a deal. once they file the clock starts ticking that then need to name the manufacturer before the PDUFA date. if they dont already have a deal, that actually gives the upper hand to the partner in negotiations. because then the partner can low ball it and hold out, knowing that IPCI would not risk a denial because they couldn't name the manufacture site. IPCI's best stance in my opinion to get what they want is ink the deal as they file. while that may not be the best to get a second pop in price, I think the company is more concerned about not being behind the 8 ball.
Doog....absolutely. PODRAS has huge potential and many applications well beyond Rexista. my comments were only generated that any logical person has to know the patent for PODRAS is at least in part what is holding up the filing. that any partner would want that to be part of the deal and therefore the patent needs to be approved. that at this juncture especially if they are making PODRAS part of this application which we know they already are, they also need to reference any patent numbers that they are relying on.
that being said, that is also why I felt the dialogue yesterday in regards to a buyout was merely that. fluff. I could see the partnership for Rexista being worth 503 million but not the entire company. PODRAS alone is worth 2 Billion easy in my opinion.
Angelo....its not a matter of trying to wear someone down. Its the "litigator" that comes out in me. My comments are based on what I know and How I interpret it. I am relying on the following sections of the applicable law. In Guidance for Changes to approved NDA which states the following. as I said there are additional tests that are required but one isnt expected to redo and submit wnat was already done. its new testing to support the new indication which usually equates to additional phase 3 tests. in this case no phase 3 will be done so one would be required along with some others.
2. Additional Testing
In addition to confirming that the material affected by manufacturing changes continues to meet its specification, we recommend that the applicant perform additional testing, when appropriate, to assess whether the identity, strength,quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product have been or will be affected. The assessment should include, as appropriate, evaluation of any changes in the chemical, physical, microbiological, biological, bioavailability, and/or stability profiles. This additional assessment could involve testing of the postchange drug product itself or, if appropriate, the material directly affected by the change. The type of additional testing that an applicant should perform would depend on the type of manufacturing change, the type of drug substance and/or drug product, and the effect of the change on the quality of the drug product.
B. Equivalence
When testing is performed, the applicant should usually assess the extent to which the manufacturing change has affected the identity, strength, quality, purity, and potency of the rug product. Typically this is accomplished by comparing test results from pre- and postchange material and determining if the test results are equivalent. Simply stated: Is the drug product made after the change equivalent to the drug product made before the change? An exception to this general approach is that when bioequivalence is redocumented for certain ANDA postapproval changes, FDA recommends that the comparator be the reference listed drug. Equivalence comparisons frequently have a criterion for comparison with calculation of confidence intervals relative to a predetermined equivalence interval.For this, as well as for other reasons,equivalent does not necessarily mean identical. Equivalence may also relate to maintenance of a quality characteristic (e.g., stability)rather than a single performance of a test
Angelo.....doing a NDA-S does allow you to skip phase 1 testing. I did say,they will have to do a phase 3 as well as "any other test that the FDA deems appropriate" you are missing what a NDA-S does. they will NOT have to prove its safe. Rexista will already have been proven safe by the fact it was approved and thru the tests they already did. The "S" will only be for the indication of does the drug prevent overdosing. what they have to prove is that Podras works as its being touted which means it prevents an overdose. the drug itself however is as safe as Oxy is safe. the question will be does the addition of PODRAS have over dosing capabilities? if it does not work and people can still overdose with Podras, then they dont get the approval. Think of it this way. you have Tylenol for pain relief you get Tylenol approved now you want to add Vitamin A and say Tylenol with Vitamin A not only gives pain relief but also heals the cuts. all they need to do is file an NDA-s and then do the appropriate tests to confirm that adding Vitamin A does indeed heal the cut. they do not have to go back to phase 1 and prove Tylenol works on the pain.
Doog...there you have it. now one just makes their own assumptions. mine was and still is, if you can go the simpler route of an NDA-S why not? Yes, you will still have whatever studies to do the FDA requires but at least you dont have all the costs associated from square one as an NDA. therefore, since it can be filed as an NDA-S one must include discussions about Podras in any deal for Rexista. so its all hinging on them getting the patent number. but hey, if people want to think the company would rather file a separate NDA, then my question is, who do you think would really want Rexista 1 ? why pay big bucks for original Rexista if IPCI is just going to come out in two years with something better? logic dictates any partner would want dibs on Podras. but that's just my thought. sorry been away all day and just now catching up to see what I missed LOL
Fabious.....there you go. I told you , well everyone, the facts are before you. PODRAS is already part of the formula in Rexista. therefore they need a patent number to attach to the filing because it will rely on that patent as well. however, just because they added it already they will not promote it as having overdose prevention tendencies. In order to get that they will need to file a Supplement and do a phase 3 and possibly other studies, in order to get to change the lable to say it has overdoes protection. I keep pointing out they only had 1 IND. but yet the FDA is already talking PODRAS. the company did not file for 2 IND's one original Rexista and one with PODRAS, they only had 1 IND. the current application will already be enhanced by PODRAS which is why they need the number. it is also why its holding up the agreement and the agreement will be inclusive of PODRAS. my guess is we get 1 PR a week or two from now once they get the actual patent with a number, we get 1 PR saying they filed and inked a deal. as I laid out previously, they must eventually name the manufacturer site and they wouldn't risk filing knowing they only have so many days to name and not have an agreement hammered out. But hey, anyone is free to disagree. that is what a debate and forums are for. I just haven't heard any convincing argument to sway my opinion yet.
In reply to Angelo. I can tell you why I fee he is wrong. I am not misleading anyone. the facts are all in front of you. I have said for some time that Rexista with PODRAS will require additional testing and yes is a few years away. but its still tied to the original filing. the exact tests that will be required will be determined when the company files the Supplemental. but I can guarantee you that is how this is going down. The company has not filed 2 IND's. one with and one without PODRAS. yet, the FDA has granted fast track designation for PODRAS. so your talking about two versions but one application with the FDA. If they were going to file a second application they would need two IND's. you do the math and still tell me the company will file an entirely new NDA down the road for PODRAS rather than just filing a supplemental? how can the FDA make a fast track status for an application or indication not before it? there is currently one application to be filed before FDA that they are intending to file and have had only one IND for it. yet PODRAS has received fast track status. clearly, the signs point to 1 application being filed and down the road a supplemental being applied for the include the additional indication for overdose prevention. therefore, the issue of PODRAS needs to ironed out now along with the potential partner. People are looking for some nefarious reason for the company not filing yet and it all makes perfect sense to me.
Numbers...really? Let me pose this to you. do you feel PODRAS would be accepted by the FDA without phase 3 trials and probably a few other safety studies to prove it works as it would be labeled. to protect against overdosing? if you feel that it would indeed need at minimal some sort of testing to prove it works, then who would you want paying for that? That is why PODRAS would need ironed out in any agreement for Rexista. you really expect me or anyone to think the company would file a supplemental NDA to an approved drug and not have discussed who is paying for it? I guarantee those issues are discussed beforehand not afterwards. the only reason it would not be discussed is 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. Not to mention who would want to partner with Rexista if you knew its already outdated once the company starts a new application for Rexista+PODRAS ?
92662...Yes, that is what I am saying. the company can submit their own test batch of the drug along with the filing so long as they apply for and receive a waiver to import a class 2 drug into the country. However, the application is quite clear that they must name the Manufacturer site in the application for where the drug will ultimately be produced. This disclosure must come before the final PDUFA date. which is why they will need to name the partner before the PDUFA date. Hence, my reasoning for why this PODRAS patent is critical to obtain because ultimately we all know they want to add PODRAS to the mix and makes more sense to do that as an NDA-S rather than starting over from square one with a new partner. My latest comments to Fabius were since this is the logical progression, they must now also be working on an agreement, so whats the chances they name the partner at the same time they file? I dont see the company taking the chance of knowing they need to state the Manufacturer site before the PDUFA date and not know if they reached an agreement in price. that puts the leverage back with the opposition. so Im betting we also see the agreement announced along with the filing
Really, I cant believe no one is following this on here.
Tekterra....just why do you think this has dragged on for months? they just found out a week ago that the patent should be approved. they dont even have that in hand yet. that would give the green light for the lawyers to get back to the lead potential partners and say OK this is where we stand whats your final offer. that then needs to be discussed with company's decision making board and then lawyers need to look over the final agreement. I can tell from you experience, those things take time when you have that many hands stiring the pot. it only takes one of those people to have a vacation scheduled and you just added another week. I recall one time we had an addendum to already in place Government contract to just add an additional 50,000 units and it took 2 months for all the signatures. and everyone was in agreement that everyone wanted the additional units and our company wanted to offer them at the same price. patience....
Fabius....I agree with your take as to minimal amount of information that will be release should include those X factors. However, we did see it before where they didn't. another concern I have is timing. I feel the filing is being hinged at least in partly, to the patent being "officially" approved for the reasons I laid out previously. now, we know they must name the manufacturer site prior to the PDUFA date in order to get approved. The question then becomes , will they file the NDA knowing they cant meet that obligation of naming the manufacturer because they haven't inked a deal? If they are as cautious as I believe they are, I do not think they would do that. if they are just negotiating, once they file, that now puts the leverage with the other party. the other party could just retract or rescind something and then IPCI would be sitting out there with a filed application and the clock ticking. therefore I think the news we will see will be two fold. the news of the filing AND the news of the agreement. any thoughts?
Fabius....I dont think anyone would disagree that any signed partnership would be stepped with milestone payments. Not only will it contain language for milestones it should also contain milestones for PODRAS if one agrees with my supposition that the company would file an NDA-S rather than start from square 1 with PODRAS. one question that still lingers is will IPCI release the details? so far they have been pretty tight lipped in regards to any of their agreements. I recall when Focalin was approved no one knew what the upfront payment was going to be. likewise the details of the Teva deal was never disclosed. My fear is they ink a 400 million deal and merely state they signed a deal with X.
absolutely, I have seen it happen in both directions. I personally have felt the stock has been driven down to these levels artificially. and I have seen typical pump and dump. its easy to do if you have a good deal of money on a low float thinly traded stock. you just wash trade between accounts and move any direction you want. Im hoping that stops soon. as for the recent buy. that's anyone's guess. it could have been due to the conference.
hondobud.....that just goes to show the high volatility and low float. very shares are available for sale right now. so if I were to say place 20,000 shares for sale at $2. and someone someone wanted to buy up say 2000 shares. they would go in order of the ones available. so say someone is wanting to sell 100 shares at 1.85 and someone else is wanting to sell 100 at 1.90 and that's all that's available. that person wanting to buy 2000 shares would buy 100 @1.85, then 100 @1.90 and then 1800 shares at my $2. so the price just went from the current 1.75 to $2. its what the other guys were recently talking about how they could see the shares available on the 2nd and 3rd levels. yesterday someone wanted to buy 50,000 shares and just happened to scoop up anyone's shares who had them set to sell like yours. there are more technicals surrounding it but that is the basic jist
Thanks guys.....like I said, I'm not saying there may not be something also holding up the filing but I feel confident in my conclusion regarding the patent. I have said I am not up on Patent law. but from what I am reading I think at this juncture they are within 5 weeks from obtaining approval. that would be inline with their latest statements from the conference for next years approval estimate they gave. people just need to be patient.
Tekterra.....you have to understand what an NDA-S is. ask yourself, do you think they will file an application with PODRAS down the road? if the answer is yes, continue. 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. if your intending on adding a supplement down the road to your existing drug then it only makes sense you deal with that in the negotiations with any partner correct? if you think yes, continue. the fact is they need to name a partner before the PDUFA date in this filing becuase the rules state they must name a manufacturer location with their drug application. that means they need to have everything ironed out in regards to PODRAS with the partner which means they must have a patent. going forward without would be very risky from a legal standpoint.
Fabius.....I agree, we dont know when all this will actually hit. People are getting anxious because we all were hoping it would be by August. now its delayed. But, I agree by years end, things will be much different. we have 1. the filing 2. probably news of partnership and if not by years end very soon thereafter as they need to announce before the approval. 3. possible ANDA approval 4. possible additional Focalin strength approvals.
My personal feeling is the filing and then relatively soon afterward a partnership all are being held up due to the patent for PODRAS. again, it only makes sense that they would file an NDA-S for PODRAS, not an entirely new application and start from scratch so having that patent is critical for the first NDA to move forward if your intending on adding a supplement to it and yes you would need to address it because that then needs addressed in any partnership. its all wrapped up into one the way I see it.
Angelo.....I agree, I dont think they will say much of anything new at the Conference. other than maybe exactly what they are waiting on. My personal opinion is the Patent which Doog just updated and showed the allowance has been mailed. so if its snail mail a couple days but if that means an email or fax that could bring on the PR we waiting for. unless its more than just that. Hence the Frustration with Management. I don't know why they can't come out and say we are held up for this or that.
ahasja....Doog gave you my response and what Angelo just said is accurate. I think you are just not understanding what an NDA-S is and how it works. the "S" stands for "supplemental". Rexista will be filed as an NDA with the nPODDS delivery system. It will get partnered and approved as Rexista. THEN once approved the company (more than likely through the Partner) will then apply for the Supplemental application for the indication of "PODRAS" in order for the company to market the drug as having anti-suicidal properties. in order to get that indication approved they will need to do Phase 3 testing and other safety tests to show that PODRAS does indeed work. they wont need to redo the original tests because Rexista will already be on the market. this will just be "adding to" the already approved Rexista. this would be the most economical way to get Rexista to market and then enhance it with the PODRAS formula through an NDA-S. this is why I feel the current filing is being held up due to not having the Patent approved for PODRAS. if your intending on adding PODRAS to the current drug then logic would dictate that any partnership would somewhere talk about it. they wont have a stand alone product of Rexista and and then try to have a second stand alone product known as Rexista 2 with PODRAS. Its all tied together.
Angelo....really? that just came to you today? seems to me thats what someone or ones have been doing for sometime. driving the price to desired direction by the buying and selling. I get that some hedge their investments. I just never understood the logic of the why. if in the end, one wants others to notice the company. hence the sprouts in this forum. and his most recent qoute "watch the share price be back to $1.60 in 5 years" the fact is that is what has happened in the past. this year is a prime example. we were sitting at $2.40 prior to Keppra approval. after Keppra it spikes to $3. a week later they announced earnings and we went to $2.25. really? and now we have seen it hit sub $1.50 since then. so, while people I feel already knew what just came to you today I still shake my head in disbelief as to what that tells the street this company has to offer.
GM Doog.....your right. lets bring it on. Im not sure if they would make a big announcement on a Friday? not to mention I still think its too soon after that notice from Patent office but again I do admit I am not up on that process. that being said, I am hoping we see some sustained action on top of yesterdays nice move. with the timing of the news article we may see some new blood and buying if they did their DD and see we are on the verge of a filing.
Doog....I agree with all you said and yes, I do believe the deal they ink will be lucrative due to the fact it will address PODRAS, at least in Rexista. which is why they need the patent. they wouldnt want the partner being able to reverse engineer it to figure out the PODRAS properties. we all are ready !
doog...thats my point. they will need to do a phase 3 for PODRAS. it makes no sence to submit another NDA. they will file an NDA-S which then they can go right to phase 3 testing for PODRAS and skip all phase 1 and BE and HAL studies. hence logic dictates from a legal standpoint that any deal with be for both versions as the company is only filing 1 NDA. it would not make sense to file a second NDA from square 1 when they can just file a supplement to the approved one? hence why the patent approval is holding up the current filing as well as partnership. it all makes sense to me. but in doing so it also gives a clearer picture as to timing. at least to me.
doog....I agree no one knows for sure. but one can use what they know to make a very educated guess. what we know is Rexista is being enhanced. we know they are only filing one application. the company can then file an NDA-S after its approved to include PODRAS. if I were the lawyer working with either IPCI or the partner, I would want the question of PODRAS known. I wound want to know if I get first dibs? will I be required to do the phase 3? all this hinges in IPCI obtaining the patent
Yes awesome news and thanks for finding it as well as the education from MOPAR. as I sated, I don't follow Patent procedure. too much else in Corporate law and Civil law and Contract law and then of course FDA. that being said,I don't see this as being "imminent" I could see them taking another week to actually have letter in hand, then send in payment and another 2 weeks at minimum for the PO to process and then issue final patent. It would be company privileged to then know if they can file without having the actual patent in hand to file the NDA or if they can file with followup submission of the actual patent before PDUFA date. we do know that that any partnership is still hinged on obtaining this patent as well as the filing because they need to list the manufacturer before PDUFA. so, my gut is telling me that everything hinges on Patent approval. will they file before having in hand? do not know.
Doog...I read where its states mailing of corrected notice of allowability. I must confess I do not have and have not followed patent procedures. a notice of allowability, is that the same as a patent approval? seems to me a strange way to say an approval is being mailed.
ahasja...good point. will they away from another 2.7 million shares? if they do then rest assured the holdup is out of their control. such as waiting on the patent approval for PODRAS etc.
Trenches....your correct if they are just a grant. I was under the impression they exercised them. I have yet to be able to find the actual PR article.
Fab...LOL, actually I thought you were talking or relying to me. I had said a little while ago I felt they would probably want to file prior to going to this event in NY which is geared towards institutional investors. as long as its within their control, if they are indeed waiting on a governmental action such as patent approval or granting of a import waiver, then they honestly don't know themselves when they will receive and are waiting just like we are.
92662...while a company may give an option its the exercising of that option that becomes the problem. SEC rules are very clear of insider buying prior to any material announcement. its a no no. now, this could just mean there will be no material announcement within the next 30 days? either way its not a got a sign. either they are violating SEC rules buy buying within that time lone or this means no news is expected within the time frame.
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