I made note you are retired and enjoy researching stock. Have you researched how the Creating Hope Act may be applied to this stock? Nice to have fresh legs around here. I think you will find the Creating Hope Act and this stock interesting. Would love your take on it. Think this company will push for it and will the law allow it to have meaning here?
If MSTX gets Fast Track priority review and orphan drug designation the PPS will take off like a rocket for sure, but I am thinking it will be a year, or more before that could start being priced into the share value. The reality is that while the Phase III trials are in fact fully funded without any danger of further dillution it is going to be some time before they near completion and are ready to file an NDA with the FDA.
The Creating Hope Act expands the cost-neutral Food and Drug Administration priority review voucher (PRV) program, allowing pharmaceutical companies to expedite FDA review of more profitable drugs in return for developing treatments for rare pediatric diseases. Since 1980, the FDA has approved only one new drug for treatment of childhood cancer, compared to dozens for adults. Despite this significant unmet medical need, pharmaceutical companies have been reluctant to develop drugs for rare pediatric diseases because it requires making an investment in products that are unlikely to cover the high costs associated with their research, development, marketing and distribution. Developing products for children is particularly challenging because of the difficulties associated with conducting clinical trials on this patient population.
Yes sir I know what it is. I know it comes into play upon approval of the drug. But I also read if a drug of this nature is designated as a rare disease by the FDA the company developing it gets extra help from the FDA to make sure no mistakes are made. Law makers gave the FDA only so much time to add on extra help just for this. If this is so. Why have we heard nothing about it around here?