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Already done. Kirin replied basically sad they are aware of our concerns.
While that wouldn't surprise me his actions aren't helping. He could've instead forwarded all communication to investor relations as opposed to do this.
Question is who told you that though
I'm hoping for back to back ANDAs from MNK. That might be able to reverse this trend.
Because I can't declare a loss :|
Well Anyone got a penny stock insider tip. Only way I'm going to make my money back on this one :(
The question is do we as shareholders have enough clout to force this issue. With all out shares combined I'm curious what our % is
The issue essentially with these two statements
The committees expressed a desire to review the additional safety and efficacy data for RexistaTM that may be obtained from human abuse potential studies for the oral and intranasal routes of administration. Accordingly, the Company intends to conduct Category 3 abuse potential studies to provide the data the Company believes necessary to support abuse-deterrent properties of RexistaTM for the oral and intranasal routes, which are required for abuse-deterrent labeling claims for such routes. The Company has an FDA approved protocol for a human abuse potential study for the intranasal route of abuse, which it plans on commencing in the coming weeks.
&
RexistaTM is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The submission is supported by pivotal pharmacokinetic studies that demonstrated that RexistaTM is bioequivalent to OxyContin® (oxycodone hydrochloride extended release). The submission also includes abuse-deterrent studies conducted to support abuse-deterrent label claims related to abuse of the drug by various pathways, including oral, intra-nasal and intravenous, having reference to the FDA's "Abuse-Deterrent Opioids — Evaluation and Labelling" guidance published in April 2015.
Doesn't sound like he is referring to the the abuse studies in that statement to me
Could get a rejection in September.
What the company really needs to do is offer some guidance on the cost and time frame to complete these studies. Then we can make some education decisions on which way this is going to go.
Another ANDA approval with mnk would go a LONG way right now in helping out.
Some nice insight there. With that many subjects it seems fairly small and can probably be put together pretty quickly since the FDA has provided the guidance already.
I guess that would be part of it but its also supposed to flag early signs of abuse so that professionals can get the person help.
Investing in Miners.
Hey guys and gals,
Looking at getting into a few miners in anticipation of the eventual electric car / battery demands.
Never invested in miners before and looking for some guidance in it. So far I've been making a list of points to consider and research and was wondering if anyone had anything to add that I should consider.
Here's a brief txt doc Ive made with some of the points. I'm sure there is plenty more.
https://www.dropbox.com/s/ck5x711ljk0zwvs/mining.txt?dl=0
Anyone got anything to add?
Hopefully the Canadian dollar gets to par again with USD. Then I'll journal my CAD shares over to US and at least when the dollar hit 70 cents again I can make 30% on exchange rate.
Well fortunately or unfortunately my investments are in registered accounts. So no loss deductions :P Holding for now.
One can hope... This fraud investigation isn't going to help perception. I don't see how you win unless you can show they knowingly went in without the studies on purpose. But either way its going to weigh on it.
Best of luck guys... Fingers crossed
Doog i'd delete yours too
Anyone know why we keep seeing PRs about the shelf that all appear the same?
Been trying to figure that out myself... I admit I haven't read it closely... But they appear to basically be the same.
In all fairness though, the ones approved without a partner have several generics on the market already... The delays by the fda have kind of ruined the chances for those two drugs
I'd imagine most of us here do or we wouldn't be here.
Why would you think they would not?
Author’s reply » Philip Mause, thanks for the question about IPCI. I am aware of them. My reservations stem from a statement by a scientist about the chemistry/science being a problem and my own business concerns about management. I will leave it there."
That fact he is quoting some mysterious scientist with no sources, and doesn't elaborate on his concerns of management tells me he's full of jack and s***, and jack left town.
Yeah I'm still kind of surprised gluco isn't partnered... I know there are several on the market but figured someone would be interested in it.
Looks like ipci's patience is going to pay off hopefully
Annnnnd the blue dye again... The same blue dye in about 30-50 different Pepsi products that people die from every day. All those athletes dieing from that poisions cool blue Gatorade.
Stall tactic for sure
Anyone still questioning being CFP 3Q?
No volume for 20-25 mins? Halted?
Yeah that was me. I copied his msg and posted it.
You saw it with your own eyes, IPCI said cash enough till June, then changed to July, and now it's enough till September. That's telling you they are also expecting delays in revenue and they are either cutting back on spending or selling more ATM. No body can be certain things won't go wrong and IPCI ended up running out of money before new revenue comes in. They are cutting it too close and investors don't like tha
A quarter with a lower loss for Q2 will show we're rapidly moving towards q3 profitability.
I agree. It essentially ensures CFP by 3rd q
This with seroquel should make us CFP by 3rd Q. It should alleviate any fears of dilution unless there is some need to push the research forward all of a sudden.
Hopefully when were cfp samsa the ATM will stop and the shorts will be done. Available shares seem so few that they have to be relying on it to cover
Even if the % is low. That with the additional focalin doses should be AT LEAST break even
What about a dropbox link
Post like that make me feel warm and fuzzy.
Cysonic can you give anymore details on your email from sec on IPCI
Let me know when your next insider tip comes or strange limos appear in the parking lot.