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He is here because he is disgruntled about food effect and a food effect related CRL. And yes everyone knows the FDA will make the call on whether Rexista is bioequivalent or not. If not, PH3 will likely be required.
ELTP holder- IPCI has worked out a deal with the FDA that they will not need to do a PH3 if they can show bioequivalence. The bottom line is their NDA will attempt to show this bioequivalence. If not, they will need to do a PH 3. IPCI PRs claim they have shown this bioequivalence. I guess it is just wait and see at this point. One other thing worth noting is IPCI issued a PR that Rexista has no food effect. Something ELTP cannot claim. And since you are here... How is the ELTP CRL going? It is my understanding the CRL has to do with food effect...
I see you guys have a lot of questions. Have any of you ever given IPCI IR an email or a call? I have done so many times and they have always given me very good answers on the questions they could. So here is a novel idea. Instead of talking on here all day about what you do not know. Take 5 minutes and shoot IR an email or give them a call... If you take the email approach, make sure you leave your phone number as they may choose to call you with the answers.
They also said a 24 hour format is something they are looking into... And said it would require PH3.
If you think about this logically, they need to show bioequivalence to Oxycontin to avoid a PH3. To be bioequivalent, it pretty much needs to be exactly the same as Oxycontin...
Samsa and all- I just confirmed with IPCI that the Rexista NDA scheduled for August is for 12 hour. So I think we now know it is 12 hour, all doses.
Numbers- You are probably right.
Numbers- They might have a 5mg too. See below:
On Jul 22, 2016 12:37 PM, "Domenic Della Penna" <ddellapenna@intellipharmaceutics.com> wrote:
It is for all 7 dosage strengths … 5mg all the way to 80mg. Covered all the bases.
Sprot- What made you crawl out from under that rock? Maybe you might be a little worried that we might see a move up?
Interesting action today so far... Might be time to start moving up in anticipation of filing.
Crimson- Thank you for asking the questions and sharing your findings.
Trenches- Thanks for the info!
grill and everyone- Is it true what people are saying about ELTP- that the CRL is about a food effect issue?
grill- I agree food effect will be a very large issue. It will certainly be a huge market advantage if IPCI can claim no food effect.
The other big one is whether or not FDA agrees IPCI shows bioequivalence. If they do, no PH3 will be affirmed. The day that news breaks is the day this stock breaks out. Everyone can talk about all the other issues, etc. But the main concern at this point has to do with that and mostly that alone.
It appears that ELTP's CRL may have to do with food effect... Pretty interesting...
Samsa- The panel you talk about that will determine if the data supports bioequivalence or not- and in effect whether or not a PH3 is required. When do you think this happens after submittal? Any estimated timeframe for time after submittal for acceptance of NDA, panel review, PDUFA? Thanks.
Amigo Mike- I do believe the question of whether IPCI was first filer on one of the Seroquel strengths was answered on YMB. I now believe the answer is no. If anyone can show me some evidence that IPCI is first filer on one of the Seroquel strengths, I am all ears. But if not, lets put that one to rest.
Tekterra- PH3 is not required if they can show bioequivalence. That is the agreement with FDA. IPCI maintains their test data shows bioequivalence. It will be up to the FDA to agree or disagree on this item. In my opinion, that will be done during the evaluation process. I do not think the FDA will give an answer in regards to this when the NDA is filed/accepted. That will happen down the road some time.
Samsa, cndrx, Doog- I agree with Samsa and cndrx. The Rexista NDA will be filed end of July to early August. I think that is the message we have been given. If people refuse to listen that is their problem. I do know that some people will try to bring this stock down come July 15th and no filing. They are already setting themselves up for this. If anyone cannot see this, then they are blind. Good luck all and look for filing end of July to early August!
Angelo- What do you mean by a paragraph 4 on Seroquel filing?
Yes, should be a big move coming soon.
The last update was middle of the year 2016. I believe second quarter went to middle of the year. So the update was indeed given. The reason I keep posting the correct timeframe is because many people keep saying June/July and in my opinion, that is incorrect. It is mid year 2016. But that is all just my opinion. If you really want to know the answer and are concerned contact investor relations at IPCI.
Yes finally close!
My guess is the Rexista filing happens sometime between mid July to mid August. If I had to further venture when exactly, I would say end of July to first couple weeks in August. I am just putting this out there so everyone's expectations are in line and people do not start to get nervous if end of July comes and we haven't hear anything.
doog- I am not pointing fingers. I just want people to have the proper expectations on when the Rexista NDA will be filed. That way they won't be saying what is the hold up at the end of June. I stand by my statement that the NDA will be filed around the end of July.
Garden Rose- IPCI is shooting to file Rexista NDA by end of July. In my opinion they will be tight on making that and it could spill over into August. But should definitely get it filed then. I know some people are saying Rexista filing in June but that is highly unlikely and look to end of July and early August for the filing.
fmgrana- It is nice to see you are still positive. But I think it is pretty clear what this means. They were very, very low on cash and the approvals/partnerships did not come. They have no choice to do a public offering at a low price to keep the doors open.
Same here. I bought some more today as well.
grill- These guys are walking this thing down by trading between them. That is why they don't want anyone to buy... They have set a goal of a certain price and that is where they are trying to take this. Anyone buying hurts their plans... They walk this down in a manipulated, concerted effort by trading between accounts. Hopefully SEC is taking the complaints seriously.
dtstx- Yes it is good news that they are still shooting for July. And I agree, sometimes things can slip a little.
Rexista NDA filing goal is still end of July timeframe. I verified this morning. That being said, lots of things need to get done, but they still are attempting to get this filed before end of July.
Sugarplum- Last I heard NDA filing is due by end of July. That was the timeframe.
Well said Sugarplum. I only blame myself for poor investing decisions. Always remember- it was your DD and your decision and be willing to accept the consequences.
Sprot- Look at the positive side. At least it was a purchase. 1000 shares may be a significant purchase for some people. It appears from his resume that he is heavily involved in charitable/non profit organizations. So by him holding 7500 shares, that could indeed be a significant investment on his part.
Sprot- The answer I got was that they believe everything is taken care of and they are just waiting on FDA to decide. The impression I got, was that PAR is on board with all this and they will begin selling as soon as approval happens. I got this info in the last two weeks.
Sprot- Try asking again. I got a different answer than you.
Fabius- PAR is not intentionally stalling. If you question this please contact IR and see what they tell you. Then report back here.
Fabius- I think IPCI's plan for the near future is to use the ATM sparingly to cover expenses.
Fabius- I for one do not believe IPCI will partner before Rexista NDA filing. That is just my opinion and it is based on what I have heard and on how the Odidi's have handled business in the past. Like you said, they feel the further along they get it by themselves, the better of a deal that they can cut for IPCI.
My personal opinion on why technical runs won't happen with IPCI is the manipulation. People are on to their little game of manipulation and are not going to jump in only to get the rug pulled out from underneath. Pretty sad... The company has done nothing wrong to deserve this and it is unfortunate that these few individuals continue to perpetrate their little game of pump and dump... Hopefully the stock is not so damaged that a truly material item of good news is not overshadowed by this nonsense.
Doog- I agree, some real news will get this thing going. That being said, I don't think technicals alone will break this thing out.