Do you know how many companies I've owned that were at $1.00 +, and went much higher, I owned SIRI at .06 what's the price now? Short like you where hammering the stock now I'm sitting on over 400K. Your voices here are useless. Again, you have no understanding of potential only the here and now.
I'll take nine years to pay off debt by the way I'm claiming a tax loss every year.
why, nomo, drum, and all
Just before Jan Options expiration date...... It's got me thinking why so many Jan $1.50 Calls. I'm just say'n.
A. Timing of Submission
A sponsor may submit a request for fast track designation at the time of original submission of its IND, or at any time thereafter prior to receiving marketing approval of its BLA or NDA. Note that the IND and potential fast track designation may be discussed prior to an IND submission in a pre-IND meeting, but a decision on designation would await submission of the IND. Although benefits associated with fast track designation may occur throughout the drug development process, from the early IND submission to evaluation of a marketing application, as a practical matter, requests should ordinarily occur no later than the sponsor's pre-BLA/NDA meeting with the Agency, as many of the benefits of fast track designation will no longer be applicable after that time.
2. Demonstration of the drug's potential
The type of information needed to demonstrate the potential of a drug to address unmet medical needs will depend on the stage of drug development. Data that become available during clinical development should support the drug's potential to address unmet medical needs and the development plan should be designed to assess this potential. The Agency will rely on summaries of available data to determine whether the potential to address unmet medical needs has been demonstrated.
Before human studies begin, the potential for a drug to address unmet medical needs will be based on pharmacologic and animal model data. At this stage, there may be little evidence of effectiveness of the drug in humans and the potential will be largely theoretical. For later fast track designation, but still prior to the completion of the principal controlled trials, available clinical data should begin to confirm or be consistent with the potential to address unmet medical needs.
III. CRITERIA FOR QUALIFYING FOR A FAST TRACK DRUG DEVELOPMENT PROGRAM
Section 506(a)(1) of the Act states that a drug designated as a fast track product is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address unmet medical needs for the condition. The fast track classification thus does not apply to a product alone, but applies to a combination of the product and specific indication for which it is being studied. The indication, for the purposes of this document, includes both the condition for which the drug is intended (e.g., heart failure) and the anticipated or established benefits of use (e.g., improved exercise tolerance, decreased hospitalization, increased survival). It is therefore the development program for a specific drug for a specific indication that will receive fast track designation. Such a program is referred to in this document as a fast track drug development program and the criteria involved in designation are represented in Figure 1. These criteria are more fully described below.
2 CBER and CDER describe their priority review procedures in SOPP 8405, Complete Review and Issuance of Action Letters (June 11, 1998) and MaPP 6020.3, Priority Review Policy (April 22, 1996), respectively.
Contains Nonbinding Recommendations
to provide meaningful therapeutic benefits to patients compared with existing treatments. Under this rule, "FDA may grant marketing approval for a new drug [or biological] product on the basis of adequate and well-controlled trials establishing that the drug [or biological] product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity." Where an accelerated approval is based upon a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity, postmarketing studies are ordinarily required "to verify and describe the drug's clinical benefit and to resolve remaining uncertainty as to the relation of the surrogate endpoint upon which approval was based to clinical benefit, or the observed clinical benefit to ultimate outcome"
Please pass on to skeptics....
Under the Subpart E regulations for investigational new drugs (Appendix 2), drug development is considered a continuum from early preclinical and clinical studies through submission of a marketing application. The regulations emphasize the critical nature of close early communication between the Agency and a sponsor, outline procedures such as pre-IND and end of phase 1 meetings as methods to improve the efficiency of preclinical and clinical development, and focus on efforts by the Agency and the sponsor to reach early agreement on the design of the major clinical efficacy studies that will be needed to support approval.
CBER and CDER have longstanding policies that describe criteria for review priority classification of marketing applications. Products regulated by CBER are eligible for priority review if they provide a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious or life-threatening disease (see Appendix 3). Products regulated by CDER are eligible for priority review if they provide a significant improvement compared to marketed products in the treatment, diagnosis, or prevention of a disease; eligibility is not limited to drugs for a serious or life-threatening disease (see Appendix 3). A fast track product would ordinarily meet either Center's criteria for priority review. Note, however, that an NDA or BLA sponsor need not seek fast track designation to be eligible for priority review.
No, I'm not an idiot; companies like star always seem to find money from some where. Shorts like you said the same thing about dndn, hgsi, arna, and so on. If you got a good product some one will fund you. Just need a run up to 5 to double my money. I can wait. PS thanks for the current stock price. Plan to buy much more below these levels.
Gotta love them shorts....
Is this another short manipulation?
It is on the NASDAQ website!!!!!!!!
The shorts know that when Dr. Mullan lays out the plan for seeking FDA approval for Anatabloc in Dec it should shoot to $5-6 easily.
Everytime I see bashers like this hitting a small cap it's usually to steal shares from retail investors. DNDN went from $2 to $55; HGSI $2 to $40; ARNA $1.60 to $13; LL $14 to $118, need I say more. They do it like clock work.