Information from GERN in December and during J P Morgan conference is important, particularly in reference to imetelstat. Because imetelstat is myelosuppressive (while it is considered "safe" in the absence of grade 4 non hematologic toxicities) at MTD (or a step below MTD), its use in combination with a highly myelosuppressive cytotoxic agent such as taxol in metastatic breast ca is not desirable, without reducing the dosages of the primary chemo therapies. However, when it is used as a single agent in various hematologic disorders (refractory and otherwise) and as a single agent as maintenace therapy in solid tumors with short telomerase, it is highly effective. While its potential usages (potential NDAs in the next 3/4 years) in AML, myelofibrosis, etc will definitely bring the PPS much, much higher than it is now, approvals in solid tumors (GERN needs a partner/partners in these areas) will bring in big revenue in the long haul. After a more sensitive assay is found for the measurement of the telomerase lengths, GERN should do more clinicals in some ca groups with short survival even after complete and partial responses (including stable diseases). My thinking is pancreatic ca.
NDA is an objective and there is a process to go with it. It is only a successful process for imetelstat that can lead to the doorsteps of the FDA. Each step of the way could create value for the COMPANY. These are the steps for myelofibrosis: sucess in Mayo (information will start to come in midyear, leading to more reporting in ASH in November and initiation of GERN sponsored trials in the US and EU). This is an orphan drug indication and it deserves a fast track review at the FDA. If the study data is very good, these studies can roll into pivotal NDA trials in the next 2-3 years. It takes time to prepare the NDA and the FDA would also take time to review and approve the drug.
The same process would apply to AML.
A biotech is a real biotech only if the platform technology is great (imetelstat is very impressive)and the development of the pipeline drugs would lead to successful NDAs (regardless how small the indications maybe). Imetetstat is a novel antisense (smaller molecule than the original ineffective antisenses) and it is a key drug in the arena of apotosis (a very difficult area to crack over the past 30 years). It is truely the first in a new class of drugs in cancer and possibly other therapeutic areas.
Franshei i dont think shareholders want to wait another 3 to 4 years. that is probably (conjecture) why almost everything has been sold off or given away over the last year or so. cleaning house for something to end this misery
It is all technical trading, till there is meaningful news. From my perspectives, I think GERN will do well this year: Mayo news (myelofibrosis and GERN new studies in this indication), AML (new studies), more senstive assay for telomerase, leading to selective studies in solid tumors (maintenance therapies), BTX stem cells diversification, ASCO presentation of imetelsat in NSL with short telomerase.....