some people who bought in the area 10-11$ last month are taking profits. Unfortunately the approval is considered "too easy". NKTR should recover later during the trading session. Volume is not high.
I hope so too, being confident to the fact that the CEO probably believes that some approvals are around the corner. In fact, the planned dilution, even we do not know its purpose, can be accomplished only if the market cap. is much larger than the actual.
Singapore: In a recent move, the US Food and Drug Administration (FDA) has decided to extend the timeline for granting tentative approval to generic drug applications. The timelines of applications filed under Paragraph IV have been increased from 30 months to 40 months for those whose 30-month stay expires between July 9, 2012, and September 30, 2015, and 30 months to 36 months for those whose 30-month stay expires between October 1, 2015, and September 30, 2016. It is expected that this period would be gradually phased back down to 30 months after the FDA addresses the backlog of ANDA filings estimated at 2,500 at present. When a company files a paragraph IV generic application in the US and if the application is challenged by the innovator, the court gives a stay on the product for 30 months. The generic company, however, can launch the product if the court rules in its favor. The company can also launch the product after this 30-month period is over if it gets approval from the FDA. However, the company has to get a tentative approval from the FDA within 30 months of the filing the application if it wants to retain the 180 days exclusive marketing rights on the product. This 30 months period has now been extended to 40 months. This move can delay the launch of generic drugs in the market. Even if the company wins the case in the US courts against the innovator company, they will not be able to launch the product if it is not approved by the agency. On the contrary, some drug makers can benefit from the extension of the time frame.
This from an article of 2012, but this does not show me why the glucophage is not still approved after 48 months since its submission, without any opposition.
the question is the following: is the FDA so busy that a long delay regards also other generic drug makers, or is the FDA not paying any respect to IPCI?
what's the problem?
At the moment, even 4 years or more are necessary to get the FDA decision. Hence, this lawsuit is useless.
when they will meet? It will be good if within 2-3 weeks. otherwise we will be in the hands of speculation. If they will meet in september, it would be better to go abroad instead to sitting every day monitoring the computer looking for something.
I textually read: "FDA rejects ZALVISO. A delay/setback for sure, but addictional agency info requests don't seem too onerous. Update monday".Hence, next time, be more exact.
last year something similar occurred to DSCO. But in that case the issues of the FDA were a bit harder. I guess that monday ACRX will drop 10%-15% less if reasoning will prevail, despite the shorts efforts of rising-up the emotional aspects. Let's remind that shares are heavily shorted and that shorts should cover especially if the drop will be limited. Hence a next short squeeze is not excluded if longs don't fall in the short trap of an emotional selling. IMO it is an error selling planning a next buying at a lower price. Let's see next!!
if it is large, it is good, otherwise I am worried because the weakness of today is not promising. Sometimes there it follows a sellof after an approval (NAVB example). Strange, but true. I am still holding!!!
let me remind you that empty bottle stocks like ACAD or SRPT do not sell anything, but their market cap is much larger.
investors and traders did not well understand that Lymphoseek is the "ONLY FDA APPROVED" radio-drug for the monitoring and detecting of sentinel lymph nodes in the biopsy in head-neck-cancers. Thus there are not other competitors.
try the website of "biopharmcatalyst EMA calendar on GOOGLE".Up to a few weeks ago it was scheduled on june 2014. Hence the delay to the 3Q should involve that the EMA decision could be in july, considering that they use to freeze all their activity during august/september. IMO
both Yahoo, and, better, Google finance have an "option" button in their menu. Other websites are stoxline and shortsqueeze (this last better for informations on short selling.
2) there are more than 5000 call options at 2$.
3) I guess that the EMA decision will be announced this month. The EMA calendar is vague, but Lymphoseek should be on the top of the agenda, not at the bottom.