Oct. 27 at 5:44 PM
$KZIA The news from the company means if the FDA are agreeable - marketing of the drug can commence, in the short term. A brain cancer drug, for treatment of childrens DIPG was recently sold for
$935 million. This drug called ONC201 had not been approved whatsoever by the FDA, at the time of the transaction. DIPG would only be a quarter of the market potential of GBM. Subsequently FDA did grant approval for selling of ONC201, pending a phase 3 study. A typical situation where accelerated approval is offered by the FDA. Once the drug is approved, it can be used for treatment of other types of cancers. re breast cancer, under off label conditions. Unknown to many investors, is the fact that 4O% of oncology drugs are sold, off label currently. This would be the intent of the company also, to get the drug into other areas, where studies and early trials are showing great success.