I serious doubt the integrity and credibility of that person. In an earlier post they claim to have an average pps of 3.85. When people lose that much, they feel duped, so they have no problem hustling newcomers. They flat out misrepresent the facts and twist them to promote their failed investment.
in vitro fertilization clinic accidently implants chicken eggs into a new jersey woman. the baby was sold to ringling bros.
my agenda is to simply know the facts. how can you or anyone else make an informed decision about investing into their technology when there are these unanswered questions? you are too lazy to even write to them and ask, but you sit here blowing smoke about rational investing and integrity. samsa has an avg pps of $3.85, and she keeps saying it is a strong buy,,,really? who has the agenda? why are you too afraid to ask them about pristiq? why won't you ask them about the new BE requirements and the "fasting" studies? do any of their andas meet the new guidance? you're #$%$ if you don't think the fda comments that caused them to rescind the pristiq application irrelevant. why don't they share these "comments" with shareholders?
every dog has its day, and this stock probably will get a pop some day. until then it is junkola.
OGD Continues Tightening BE Requirements for Extended-Release Products (Bob Pollock)
This is some of the most extensive testing we have seen for an extended release product and is likely a result of the some of the failures of extended-release generic products that have come to light after approval and marketing. Joe Graedon’s web site the People’s Pharmacy in speaking about extended-release generic products states: “The rules and regulations that the FDA relied upon for decades to approve long-acting generic formulations was, in our opinion, flawed. It did not take into account hour-to-hour blood levels but lumped everything together into something called the AUC (area under the curve). This allowed the FDA to approve generic drugs that actually performed quite differently from the brand name product they were supposed to be mimicking.” Well, while I don’t always agree with Joe, in some of these cases, it is clear that FDA learned more about the products performance after approval, but did act to revise the guidance and take necessary action when a problem was found. Is the system perfect? – likely not but there are well over 15,000 generic products that have been approved since the passage of Hatch-Waxman and there have only been a handful of product problems. Granted, if you are a patient that was impacted by this handful of products, then it is a big deal, but it looks like the Agency is fully engaged in trying to assure that criteria for these complex products do take into account what they have learned from other similar long-acting products.
right march 3, 2013. and no they didn't reapply 2 over 2 years ago, it hasn't even been 2 years yet. look at the dates and get your facts right before you discredit what you cannot comprehend. you have zero credibility.
"Based on the FDA's preliminary review and comments on the Company's ANDA for generic Pristiq, the Company plans to repeat one of three bioequivalence studies for the product candidate. The Company will amend its existing application for generic Pristiq to include the new study upon its successful completion."
no, par got the drug approved and performed the BE study, not ipci. it is a fact. why was wrong with the pristiq BE study?
simply cut and paste what was quoted at the top. the company made these statements "Based on the FDA's preliminary review and comments on the Company's ANDA for generic Pristiq, the Company plans to repeat one of three bioequivalence studies for the product candidate. The Company will amend its existing application for generic Pristiq to include the new study upon its successful completion."
this has some great volatility with a nice range. I got stopped out on my long position, but I think it will hold near $40 for a while. maybe some good day trades until they report actual script numbers. it appears gild is the preferred choice at the moment.
what about the pristiq application? why did the fda advise them to withdraw the application due to BE issues? what exactly were the issues?
did you find out what happened to pristiq? what was the issue with hypermatrix bioequivalence studies? did they conduct the study again as they said they would? did it fail? it has been almost 2 years, it does not take that long to perform a basic BE study. why haven't they resubmitted the anda? would you consider it material information? I would.
what do you mean? I am posting direct quotes from their SEC filings. it can be easily validated by anyone. why don't you email them? are you afraid to face the facts?
I'm basing it on their proprietary delivery system, hypermatrix. It either works or doesn't. obviously, there is an issue, and no one is addressing it. they have one drug approved, but if you read the facts, PAR paid for the BE studies for focalin not IPCI.
institutional ownership is less than 8.5%. net activity is negative -362,877 shares. to claim the float is minimal is rather misleading, imho.
All I am saying is; email them and ask why it was rejected, and when will the confirmation study be completed? They stated "based on FDA review the Company plans to repeat one of three bioequivalence studies for the product candidate -The Company will amend its existing application for generic Pristiq to include the new study upon its successful completion." The original ANDA was filed in 2012, they made that statement in March of 2013. Here we are in 2015 and not a peep from management about this. At this point, one can only ASSUME the BE study was not successful. If that is the case, this stock is worthless imho.
I would suggest you look into why the Pristiq BE study was rejected, and why it was not resubmitted. Then cut your losses, make like a fetus and head-out.
stevenson904 aka tony the pumper. I've always known it was you. just like samsa pretending to be new to the stock. for such a small board there sure have been a lot of sams over the years. more posts than shares traded from the pumping pit of deceit.
lol, how will I be able to tell? all of your posts are misleading crystal ball type predictions of huge profits with zero risk.
how do you valuate a company when they keep changing estimates for no apparent reason. the statement above contradicts earlier statements. so if it is a "typical disclosure", it is to also a change to prior guidance, imo.
theman, these people are professional boiler room #$%$s. my username was actually created to mock the person. if you enter my name into a search engine, you can find the boiler room #$%$ who pumps this stock. they are a well known group out of Germany.
Stevenson posts on that ihub board and stock house as someone named tony. he used to post here under rubinstein. they are all part of a clip joint imho.