First time ever that a drug company did this in NDA. This threw the whole Phase 3 trial result in QUESTION. Any future trial result will be looked at very critically.
Sentiment: Strong Sell
"The CRL identified deficiencies related to the dosing algorithm for the label. Specifically, the proposed titration scheme for clinical practice was significantly different from the titration scheme used in the Phase 3 trial leading to discordance in titration decisions between the Phase 3 trial and real-world clinical practice."
So odd the company would change "the titration scheme" on the label from its P3 trial. Very SUSPICIOUS !!!
I see it differently. The management would have relased the news immediately if it is positive.
Understand you don't want to hear this, but we have to be prepared for the worst. I'm still holding my 100 shares to see what happens.
If LPCN has received approval, it would have been announced by now....
I was skeptical of Brexit and lightened up a lot before the vote. Not sure of LPCN and need more info. Then again I only have 100 shares of LPCN left.
Does LPCN work with a manufacturer? Has the FDA inspected it? If so, what's the result? These are Important issues to consider in addition to the drug itself.
1) A dip in production levels out of Colombia due to the excessively dry El Nino weather which was encountered in many of the country’s coffee districts over the past six months.
2) The prospects of frost to come to Brazil which started earlier in the day yesterday, was confirmed in the outlook by one of the local weather forecasters in Brazil.
3) The upward impetus of commodities in general with the support of a continuation of the softer US Dollar.
June 9, 2016 / Coffee Holding Co., Inc. (the "Company") (JVA), announced today a new partnership with Smart & Final Stores LLC, a value-oriented food and everyday staples retailer operating 290 grocery and food services stores under the "Smart & Final," "Smart & Final Extra!" and "Cash&Carry Smart Foodservice" banners in six western states, with an additional 15 stores in northwestern Mexico operated through a joint venture, to produce their entire line of private label coffee products under their Ambiance private label brand name.
Keep doing the right thing and the money will follow.
Those were new positions in the 1st quarter; plus 38 institutions increased their shares in ESI. On balance, the institution ownership has gone up to 75.96%. I couldn't resist the great buying opportunity and bought 1,000 shares at this rediculous low price today. ESI is doing just fine.... Profitable and debt has gone down.