After the phase 1-3 trials:
"New Drug Application (NDA)--This is the formal step a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the United States. An NDA includes all animal and human data and analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured.Application Reviewed Icon
When an NDA comes in, the FDA has 60 days to decide whether to file it so that it can be reviewed. The FDA can refuse to file an application that is incomplete. For example, some required studies may be missing. In accordance with the Prescription Drug User Fee Act (PDUFA), the FDA's Center for Drug Evaluation and Research (CDER) expects to review and act on at least 90 percent of NDAs for standard drugs no later than 10 months after the applications are received. The review goal is six months for priority drugs."
This sonofabitch should be in jail. He's been hyping PANW for months, sucking all the little guys in at the top, screaming how this cyber-security company was "best in breed." And now that we've all committed our cash to buying shares of this company, he comes on on a Friday night without warning and after the market is closed and hits the stock with a "Time to sell" command, driving the share price down in after-hours trading by four dollars in a nano-second and wiping out everybody's profits who got in over the last few weeks while he was still hitting the "Buy, Buy, Buy" button. No doubt, Cramer and his buddies must have started shorting the stock at the $108 level it reached today, just before he came on the air to tell everyone that the stock had gone up too far and "pigs get slaughtered." Cramer's "charitable trust," however, is doing just fine, I'd imagine, now that he's got even more of my money and the funds of thousands of other little suckers too. I'm tired of being burned by this little bald-headed creep and his nightly Soupy Sales clown routines on CNBC. I'm swearing off forever and never watching this snake-oil charlatan again. I hope the thousands of other suckers who watch his nightly antics and con game stop watching too and drive this cretin off the air for good.
Yet, ANSS’ low RSI value isn’t the only reason to have some optimism over a coming turnaround, as there has been plenty of positive earnings estimate revision activity as of late. This is especially true when investors take a deep dive into some of these estimate revision stats and recent changes to Ansys’ earnings consensus.
Over the past two months, investors have seen 3 earnings estimate revisions move higher, compared with none lower, at least when looking at the key current year time frame. And the consensus estimate for ANSS has also been on an upward trend over the past 60 days, as estimates have risen from $3.07/share two months ago to just $3.08/share right now.
If this wasn’t enough, Ansys also has a Zacks Rank #2 (Buy) which puts it into rare company among its peers. So, given all of these factors, investors may want to consider getting in on this stock now (or holding on), as there are some favorable trends that could bubble up for this stock before long.
"The U.S. Food and Drug Administration said on July 10 that the sNDA expanding Relistor's indication to include chronic non-cancer pain patients with OIC can be approved on the data previously submitted in that filing. The decision follows Salix's appeal of the agency's Complete Response Letter on the filing two years ago and an Advisory Committee convened by the FDA last month. Salix submitted to the agency on July 25 information required for final approval, and we expect a two-month review.
Salix has said it intends to meet with the FDA as soon as possible to discuss a path forward for oral Relistor for the treatment of OIC in patients with chronic, non-cancer pain.
Results from two trials of the Company's small molecule PSMA imaging agent for prostate cancer, 1404, are scheduled to be presented at a featured oral session during the annual meeting of the European Association of Nuclear Medicine (EANM) in Gothenburg, Sweden on in October.
The phase 2 complete study results involving 104 patients are to be presented by Dr. Gabriella Dabasi of Semmelweis University.
Dr. Shankar Vallabhajosula of Cornell University's Medical College is to present phase 1 pilot study results on nine patients."