If the fly on the wall could speak after a few beers, she may say that in six months there will be an offering of 20 million shares at the price of 1.25. Mark this post, lose lips sink ships.
You did not understand the post. I realize at least 4 years until NDA, I was stating that it would take another 10 months after the NDA. 10 months more, even if they reach step 12, the last step.
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.
Bumps in the Road
If the FDA decides that the benefits of a drug outweigh the known risks, the drug will receive approval and can be marketed in the United States. But if there are problems with an NDA or if more information is necessary to make that determination, the FDA may issue a complete response letter.
Common problems include unexpected safety issues that crop up or failure to demonstrate a drug's effectiveness. A sponsor may need to conduct additional studies--perhaps studies of more people, different types of people, or for a longer period of time.
Manufacturing issues are also among the reasons that approval may be delayed or denied. Drugs must be manufactured in accordance with standards called good manufacturing practices, and the FDA inspects manufacturing facilities before a drug can be approved. If a facility isn't ready for inspection, approval can be delayed. Any manufacturing deficiencies found need to be corrected before approval.
"Sometimes a company may make a certain amount of a drug for clinical trials. Then when they go to scale up, they may lose a supplier or end up with quality control issues that result in a product of different chemistry," says Kweder. "Sponsors have to show us that the product that's going to be marketed is the same product that they tested."
John Jenkins, M.D., director of CDER's Office of New Drugs, says, "It's often a combination of problems that prevent approval." Close communication with the FDA early on in a drug's development reduces the chance that an application will have to go through more than one cycle of review, he says. "But it's no guarantee."
The FDA outlines the justification for its decision in a complete response letter to the drug sponsor and CDER gives the sponsor a chance to meet with agency officials to discuss the deficiencies. At that point, the sponsor can ask for a hearing, correct any deficiencies and submit new information, or withdraw the application.
1.Preclinical (animal) testing.
2.An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials.
3.Phase 1 studies (typically involve 20 to 80 people).
4.Phase 2 studies (typically involve a few dozen to about 300 people).
5.Phase 3 studies (typically involve several hundred to about 3,000 people).
6.The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet.
7.Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.
8.After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
9.If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness.
10.The FDA reviews information that goes on a drug's professional labeling (information on how to use the drug).
11.The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
12.FDA reviewers will approve the application or issue a complete response letter.
Inherently apparent that the people that oppose this statement are in denial or lack the skills of competent investing. The negative attitude against this statement tells me these people have lost money on their investment, so any stated logic is taken as a threat instead of friendly advice, by the way, I have made money on this stock, so my $$$$#$%$(&&U^%RR opinion caries weight. I was a buyer at 1.88 and sold over 2.
Yes this stock has potential, but their are a lot of questions, will they burn their cash and have to make another offering below 2 ??!!!!
For those willing to hold and not sell with a loss, sell a covered call and sit back.
When the stock was 3.56 I said it would go down to 1.84. Ten days later it happened, that is not useless. Lesson one, when you think nothing can wrong, it will.
To many ifs. Stock should be 100 if there was no risk. If you listened to me two weeks ago you would have made a fortune. Not useless
perhaps more dilution, 15% correction coming, no positive income for two years, AND WHAT HAPPENS, NO APPROVAL, MAJOR SIDE AFFECTS, OR ANOTHE COMPANY HAS A DRUG TX THAT IS BETTER.