So he looked at my huge list of supplements and rapamycin ( which he had never heard of). So ID says to me: 1. You know all of these “vitamins” that you take have been “proven” to do more harm than good. 2. Look at you, you’d better stay out of the sun, you’ll get skin cancer ( ignoring my vit D level of 60, and that 90% of skin cancers are benign c/w most cancers associated with low D that will actually KILL YOU). 3. What’s this rapamucin stuff you’re on? You know you shouldn’t take antibiotics for too long. 4. Why do you want an echo? Did you have a heart attack? 5.Where’s your PSA level? After all, it’s all we’ve got. ( So better to get a test that doesn’t effect mortality rates because “it’s all we’ve got”.
Sales of a substantial number of our ordinary shares in the public market, or the perception that these sales might occur, could depress the market price of our ordinary shares and could impair our ability to raise capital through the sale of additional equity securities. We are unable to predict the effect that sales may have on the prevailing market price of our ordinary shares. To date, the lock-up period has expired and substantially all of our outstanding shares are eligible for unrestricted sale. Sales of shares by these shareholders would likely result in the supply of our ordinary shares far exceeding the demand for our ordinary shares and could have a material adverse effect on the trading price of our ordinary shares.
When you say the Pine Bark gives you the same effect, do you mean the benefits of increase nitric oxide (but presumably without the headaches)?
The accelerated approval pathway is most often used in settings in which the course of a disease is long and an extended period of time is required to measure the intended clinical benefit of a product, even if the effect on the surrogate or intermediate clinical endpoint occurs rapidly. Thus, accelerated approval has been used extensively in the development and approval of products for treatment of a variety of cancers in which the goal of therapy is generally to improve survival or decrease morbidity and the duration of the typical disease course requires lengthy and sometimes large trials to demonstrate a clinical or survival benefit.
Tejero, J., Hannibal, L., Mustovich, A. & Stuehr, D. J. Surface charges and regulation of FMN to heme electron transfer in nitric-oxide synthase. J. Biol. Chem. 285, 27232–27240 (2010).
The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. If we are found to have improperly promoted off-label uses, we may become subject to significant liability.
Recently I had to go see my idiot doctor( ID) to get an insurance referral for an echocardiogram that I want to check my cardiac ejection fraction. I’m positive that it’s gone up since rapamycin 3 months ago because of the way that I can now take hills.
We may not be able to complete or commence the clinical trials that would support our submission of an NDA to the FDA, a Marketing Authorization Application or MAA, to the EMA or any similar submission to regulatory authorities in other countries. Drug development is a long, expensive and uncertain process, and delay or failure can occur at any stage of any of our clinical trials. The fact that the FDA, EMA or other regulatory authorities permit a company to conduct human clinical trials is no assurance or guarantee that the trials will be successful. On the contrary, most candidate drugs that begin clinical trials do not prove to be successful and do not result in the filing of an NDA, MAA or similar filing. Drug candidates that successfully complete one phase of clinical trials may prove unsuccessful at a subsequent phase. Human clinical trials are very expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements and in part because the results of clinical trials are inherently uncertain and unpredictable. Regulatory authorities, such as the FDA, may decline to permit a clinical trial to proceed or may suspend a clinical trial that it has previously permitted to proceed. Additionally, the clinical trial process is time-consuming, and failure can occur at any stage of the trials. We may encounter problems that cause us to abandon or repeat clinical trials. The commencement and completion of clinical trials may be delayed by several factors, including:
Market exclusivity provisions under the FDCA also can delay the submission or the approval of certain applications. The FDCA provides a five-year period of non-patent marketing exclusivity within the United States to the first applicant to gain approval of an NDA for a new chemical entity. A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, the FDA may not accept for review an abbreviated new drug application, or ANDA, or a 505(b)(2) NDA submitted by another company for another version of such drug where the applicant does not own or have a legal right of reference to all the data required for approval. However, an application may be submitted after four years if it contains a certification of patent invalidity or non-infringement. The FDCA also provides three years of marketing exclusivity for an NDA, 505(b)(2) NDA or supplement to an approved NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example, for new indications, dosages or strengths of an existing drug. This three-year exclusivity covers only the conditions associated with the new clinical investigations and does not prohibit the FDA from approving ANDAs for drugs containing the original active agent. Five-year and three-year exclusivity will not delay the submission or approval of a full NDA; however, an applicant submitting a full NDA would be required to conduct or obtain a right of reference to all of the pre-clinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness.
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the Registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. o
Li, J. H. et al. Smad7 inhibits fibrotic effect of TGF-Beta on renal tubular epithelial cells by blocking Smad2 activation. Journal of the American Society of Nephrology: JASN. 13, 1464–1472 (2002).
Polymeric micelles represent a specific class of PLG-based drug-delivery nanoparticles, whereby a diblock of polylactide and polyethylene glycol (PEG) with hydrophobic and hydrophilic regions respectively allows for self-assembly of the polymer chains into 50-nm nanoparticles. The resulting core-shell constructs have PEG oriented on the surface. Moieties conjugated to the surface are used to target the nanoparticles to biological sites and to minimize toxicity. Genexol (paclitaxel) by Samyang is an example of a PLG polymeric micelle product on the market. Paclitaxol is encapsulated within the hydrophobic core of the polymeric micelle, and the product is indicated for the treatment of breast, lung, and ovarian cancers. The PLG polymeric micelle technology enhances the solubility of paclitaxel and allows significantly higher dosing of paclitaxel to patients without additional toxicity (15).
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