Growing awareness of FDA unbelievable backlog

"Clinton’s proposals are a mix of programs that build on policy already in the Affordable Care Act, including caps on out-of-pocket spending, and Democratic standbys like having the government negotiate prices directly with pharmaceutical companies

Specific proposals:
- Limit how much patients spend out-of-pocket for drugs to $250 a month, or $3,000 a year
- Make drugmakers spend a minimum amount on research and development, similar to Obamacare mandate on insurers to spend minimum percentage of revenue on medical care
- Bar tax deductions for drug ad spending
- Fully fund FDA’s Office of Generic Drugs to clear generic drug approval backlog

Just bought 2k @ 2.16

Right Angelo,
strongly agree.

That's what I pointed out last week. If PRODRAS is going to be working as promised I think we will be skyrocketing

Thanks Guy.

Too bad that IPCI wasn't mentioned in the article when talking about the 90% oral abuse

"Another problem is that the current technologies focus on preventing tampering with the pill — crushing, chewing, dissolving. But more than 90% of opioid abuse is oral. Most users just take more pills than they should."

Do I remember correctly that IPCI has a technlogy that works well for oral abuse (if you take more pills thant allowed then the effect of the drug is strongly diminished) ?


Another problem is that the current technologies focus on preventing tampering with the pill — crushing, chewing, dissolving. But more than 90% of opioid abuse is oral. Most users just take more pills than they should.

+1 here !

Those incremental shorts were opened BEFORE the FDA U-turn....coincidence ?

Would be soooo funny to have an approval right now and watching them desperate to cover ....but this would be too nice to be true

expecting 1 approval of 4 I think is a realistic/conservative answer, based on statistics. Saying more two would be average...

we just have to wait and see...and that is why is so frustrating

I agree...and market action is going to push the price easily below 2.

I hope that they will push ahead the partnership agreements, which of course will be less lucrative for IPCI given thei current cash position...but otherwise thay have to issue new shares to some institutional.

Company's silence or inaction in these case could destroy shareholders value and take a very long time to recover.

Angelo,
what could be the cumlative value of the 4 pending ANDA ?

30$ per share (conservetive) ?

Then there is the potentially expolsive Rexista/Prodras.

Am I crazy to think a 100$ per share in 5yrs based on numbers and projections and just dreams ? (Doog...I know what you're thinking LOL)

We need news/company PR otherwise no matter how promising is the pipeline we are going down on really low volumes.

It's disgusting to see FDA (in)action or bad-action, anyway thruth is we have make a +60% to get back where we were in mid July.

This over-correction for the FDA incompetence has to be stopped giving shareholders some PR or pushing forward the next step of pending partenrship

Got it now.

LOL

Just added a few @ 2.47.

I'm wondering: how many shares do approximately IPCI InvestorHub forumers own all together ? Do we reach 1mln ?? Should be like 3.5% of the company

Not interested in the number per se, but on how much % of the outstanding shares do we represent.

This could also be interesting to calculate an rough free floating shares amount.

we are in the FDA hands...and now we all know what this could mean.

Yesterday's market action to me showed that some players are expecting the company to raise new cash (dilution) and therefore seeing price going down.

I hope (but I doubt) that IPCI makes now some move, otherwise our pain and frustration is going to increase.

What just happended with the FDA saying "Oh, you know what ? Our previous decision was wrong" it is scaring me to death and making me think that everything is possible with them...even to wait other 12 months before a new approval.

Yesterday I added just a few shares, hoping that the FDA will try to avoid possible lawsuit (loss of potential revenue) getting us the Glucophage or Protonix approval !

May the force be with us

Zacks cut IPCI rating @ SELL.....RIDICOLOUS...would love to read their reasoning.

http://sleekmoney.com/intellipharmaceutics-intl-lowered-to-sell-at-zacks-ipci/346446/

Hi Doog,

I was thinking that yesteday volume and price action on IPCI was very impressive and it makes me believe that this was just the appetizer of what will happen when big news will hit.

also, as some already pointed out, the FDA "reversal" decision is something very RARE (to me unique) which underlines the positive relationship with our IPCI.

Let's see if today some day-shorters (Always coming in action when a small biotech jumps) will get burned.

Once we will pass 3.75 it should be fun (I'm not saying today)

They will be brutally squeezed out....at least I hope so !

Ticino, Lugano

Angelo,

if I get it correctly, I'm not sure it's the best strategy to implement with a stock like IPCI.

Jus think it the price consolidates at around 4 (which could realistically happen once we have 5mg approval on Focalin) and then a mega-deal on rexista hits...

...probably we would jump above 10 and having sold PUTs at 7 or 5 would hurt you a lot.

Aa I wrong in this reasoning ?

ei b00n are you in Switzerland ? If yes, which part?

Count me as well for the Greece trip. Sitting now on 35K shares

Recent Market action I think just reflects the usual strategy for small biotech; short each time there is a spike up and remaining cash for the company is drying up.

FDA decision to require new bioequivalence just materialized the idea that IPCI will need cash in near term and therefore will issue new shares (I'm not telling that is what will happen).

Now, if FDA keeps on stalling on other pending approval the price will deteriorate because shorts will increase their convinction about future diluition.

Even if we think this stock is cheap, will soar, it's a bargain....we just depend on FDA burocracy...and nobody can assure us that future delays/complications will shift approvals even further.

I recently added more shares, but I've seen lot of times small cap stocks being hammered on low volumes.

And what is disturbing me is that a minor news on new bioequivalence requirements had a much bigger impact on the price than those Amazing regarding Rexista and Prodras..

Wow ! Don't remember who on this board recently wrote that at Maxim they don't really know what they are doing (paraphrasing).

target price before recent developments: 7

target price considering no phase 3, fasat track, etc... : 7 !?!?

are they serious ?

Shorters in action. we need some big buys by the end of the day to get them under water.

I'm thinking about the increasing negotiating power that the last week is giving IPCI when it will seat for a partnership deal closing.

Also this news sequence woul probably start to put some light on the company, making it a little less unknown than before.

Now the 5mg approval by the end of the week would just be perfect !!

Good luck everybody

Hei Doog,

could it be that tha sentence regarding the 5mg Focalin is intended to sound like: "Come on FDA. We are waiting". Otherwise I don't understand the reason to mention that they don't know anything about the approval.

The news about the real estate Agreement really sounds like the Company has big plans. To me it's great news.

Go IPCI Go !

I think you are right, in fact I'm holding strong with my 35K shares.
I don't need that money and I really would like to organize a celebrating IPCI dinner in 2 yrs from now with many of you.

Shorters are playing their game...and they will continue until a combination of 2 or 3 news will push the pps higher and higher

Frustrating...to say the least.
How can be that with this incredible news the stocks is still under 3usd per share?

Are we the only ones who see the incredible potential here ? Are we missing something in terms of uncertain outcomes which the Market seems to be heavely considering ?

I share most of the points of all you guys longers as me, but days like Yesterday make me wonder: are we lucky because early buyers of a future biotech star or are we just fall in love with the stock ?

Another biotech would have doubled on a news like that of Yesterday...so ...again are we lucky ?

If nothing bad happens in two years from now I will still be an IPCI holders, maybe planning for a celebration dinner with some of you...but right now I'm feeling confused about the market action.

Anyway...I'm not selling a share...but considering buying some more if in the coming days would be below 2.80 (hopefully not)

Ciao
Fabio

Is FDA still active or has been wound down ?

The wait for generics approval has become ridicolously high, even considering all the great insight and explanations given on this board.

Come on FDA....let the IPCI party begin !

Doog, this is what I've always believed myself, but I don't understand why, given that to us it seems just a matter of time before we get a huge jump, ...don't understand why, I was saying, instead of MM shorting and trying to make small gains each day on the downside, they don't just push pps up and unload for big big gain.

to me, thery are picking up nickels in front of bulldozer....but start to feel uncomfortable.

good luck to all of us LONG guys

And slowly, with very controlled market action, we are going back again.

No matter if we had some positive news over the recent months.

Could it be that some new shares are being issued each time the pps goes up ? Just wondering. Company out of cash soon and probably the are starting to think the FDA delay is gonna extend for long?

I've seen a lot of biotech shares going up and up on just rumors and minor developments. I've always thoght that speculation is working both directions....but not for us, not for IPCI.

what if we get an approval ... we go up 20%....to less than we were one year ago ? (just saying out of frustration).

we receive very positive Analyst upgrades/updates and....pps goes down on very low volumes....go figure.

Always LONG, but still suffering

Doog you r right on evrything. My point is that the stock has not a biotech behaviuor, because it would otherwise be in 4-5 pps based on all the catalyst and developments we all know about. Just it. Considering how many shares of ipci i would be considered a strong supporter of the conpany. Glty and all longs

Low volumes and pps way below 3...this stock is used by somebody as a way to make money shorting or selling at each peak. This is frustrating to say the least. Still continue to read People saying good times are coming...okok...but what I've been seeing over the last months is that some catalyst are kicking in but the stock doesn't jump on the news and doesn't consolidate either. And that's not s good sign. Hope to see sometging different soon...but we are living on hope since more than one year now

Almost 10% of the Company sounds really interesting for us small retailers, but consider that those shares could representjust 1% of AUM of the Fund....so just a small bet for them. Just to say that even big boys make some mistakes.
Having said that I consider the news as really positive.

Just would like to see those shorts being squeezed and looking desperately for shares to be boght back.

Come on FDA ...come on !

Great !

This means the floating shares are now exiguous. considering the 1million oh shorts I would expect a biiiggg jump as soon as news hit.

On the other side this also means that the MM can do whatever he wants....driving the price down with no effort.

A new Buy recommendation seems to be out. anyone has access to it, please share it.

Mackie Research Capital Corp TP 11.00 speculative buy (source: Bloomberg)

sorry guys, that's all I have

The only good (for IPCI longs) reason could be that potential partners/investors are negotiating to have a person of their own in control of the financial aspects of the co. Honestly I don't like the idea of him leaving (except for the above mentioned hypotesis); as you saied...why going somewhere else if you have a job in a company that is about to skyrocket?

CFO Shameze is leaving IPCI to be CFO in Profound Medical .
Not sure how to see the news...beacause I'm not buying that he's leaving for a better career opportunity.

Disclaimer: I am Long with 25K shares

Barron's reporting Maxim recent upgrade and comments ....this should help gain some visibility

http://online.barrons.com/articles/two-drug-firms-fighting-opioid-abuse-1412867547

I have to agree to almost everything.

why remaining listed if you don't show interest in shareholder value and in communication to the market.

Once the market loses confidence in one company it become very difficult to gain it back.

I'm starting to be worried and just don't wanna think what would happen in case of some new disappointing news....like rexista devolpmentes or some delays in anda approvals...

unfortunately I'm in BIG (at least for me)...and this fall just eroded all my gains (potential).

Hope for some GOOD news asap