A phone call is always standard procedure followed by a formal letter when it comes to trial holds. It's even on the FDA procedural website. I looked this afternoon.
Pretty harsh words. The Dr. is basically saying JAK inhibitors will never be disease modifying drugs and all the additional Phase III trials being conducted on them are for the benefit of drug companies and not cancer patients. Investigators should be directing their efforts towards testing drugs that could potentially cure, not just relieve symptoms. I can understand why he is so excited about imetelstat.
Agree. I don't think the market has factored in the unique trial design. I mean, a $30 million market cap in this day and age for a biotech with a drug addressing a billion dollar market is an insult.
Furthermore, not understanding that stocks with limited institutional ownership are short-sale constrained vs. stocks with large and growing institutional ownership, will get you what you deserve.
“So, it really does NOT make sense that the short interest has increased over the past several months. NOPE, just doesn't make sense!!!”
It doesn’t make sense to retail trolls of limited experience and intelligence. Not understanding the difference between increasing short interest in up-trending stocks vs. down-trending stocks, nor the function of short/long arbitrage during share offerings, will get you what you deserve.
InsiderScore is reporting that GERN had the largest percentage increase in institutional ownership of any biotech for the 4th quarter of 2013. Based on form 13 filings, institutional ownership went from 29.65% at the end of the third quarter to 38.87% at the end of the 4th quarter. That’s an increase of 31.45%. This does not include the huge buys FMR (and other institutions) made with the recent share offering.
Institutional buying doesn’t guarantee success, but this is considered smart money. I’d rather invest with the smart money than bet against it. What do the institutions know that the knucklehead shorts on this board don't?
It's been my experience that this type of short behavior is not what it seems. These "shorts" most likely represent long hedge funds and institutional investors looking to keep a lid on the price until they can get their orders filled.
I have a feeling that everyone who made large profits on this stock in 2013 is waiting to sell in January to push taxes out until 2015. Institutional ownership is less than 20%, so this is principally retail owned and selling in January would be the prudent thing to do given the obvious headwinds going forward.
I don’t like what I’m reading about the government investigation and the increased competition from new products coming on the market. The company is dealing with investor lawsuits and apparently a lawsuit from an existing officer claiming he was scammed out of his fair share and prime patents. Does anyone really think they are going to push this market cap much higher? I don’t. Looks to me the path of least resistance is down starting January.
These are allegations made by someone who works at INSY regarding the current government whistleblower investigation of INSY sales tactics:
They paid every single doctor who has ever written a drug in the class to be a "speaker". 90% of them never even spoke to a group because if every doctor is a speaker who is there to speak to?
Has been confirmed docs were receiving stock options to prescribe.
Reps were waiting outside of offices for patients to walk out and detailing patients (very illegal).
Reps spoke off-label promoting it for non-cancer patients even though the FDA is very strict on its indication for cancer pain.
Reps personally filled out prior authorization forms looking at private and personal patient info such as date of birth social security number medical condition etc. again this is very illegal.
And everyone thinking "nothing" will come up in the investigation, yes things will. I work for the company. This investigation was opened by whistleblowers at our own company who were disgusted at the unethical behavior. There is supporting documentation. I guess in life you can't expect to get away with these things. Watch American greed on MSNBC or CNBC I forget. You always get caught.
The problem isn't the sales data. The problem is how these sales are being made. There's a whistle blower involved here. That's how these investigations start. And if it's found the company is promoting Subsys for off-label use, and it's not too hard to prove that, the company will take a huge hit to sales and earnings, not to mention having to pay fines and legal fees. It looks to risky to hold at these lofty prices. After the charges are settled would be a better place to go long.
This investigation will likely not end well for Insys. The settlements below all started with a subpoena from the Office of Inspector General of the Department of Health and Human Services:
“The pharmaceutical company Abbott Laboratories said on Monday that it had reached an agreement with the federal and nearly all state governments to pay $1.6 billion in connection with its illegal marketing of the anti-seizure drug Depakote.
The settlement comes as the Justice Department and the states have increased scrutiny of the sales and marketing practices of pharmaceutical companies, particularly in cases in which they market drugs for uses that are not approved by the Food and Drug Administration.
Last year, GlaxoSmithKline, the British drug company, agreed to pay $3 billion to settle civil and criminal investigations into its sales practices for several drugs, including the diabetes drug Avandia. In 2009, Pfizer paid $2.3 billion to settle similar charges. Several other pharmaceutical companies have also reached multimillion-dollar settlements over their practices.
Abbott illegally marketed the drug for schizophrenia and agitated dementia, even though it was approved only for treatment of seizure disorders, or mania associated with bipolar disorder and migraines, according to a media release from the Justice Department. “
These companies market dozens of drugs. Insys markets only one.