The normal process is to list the trial without the sites then either add the sites in blocks or when the sites come on line. Janssen is running the show they know what they are doing. Just because it is your first rodeo you do not need to spread undue fear about trial sites. Running around tilting at windmills does no one any good.
AST jumps 12% on the trial Balloon VAC1 the market forgets that VAC1 will not go to phase 3 because it costs to much per patient to make it viable. Okarma made it clear when he said 4 months of cleanroom time per patient puts the cost of VAC1 out of reach. VAC1 was to prove the concept for VAC2 the of the shelf multi Cancer targeting Dendridic Cancer Vaccine. VAC2 has been shipped out to the UK for a Phase 1 trial and AST retains rites to reaquire VAC2 post phase 1.
beaver you know about the typo but you do not know about the patent for the oral version that the patent 8,906,615 allows to be made. Oligonucleatides that are constructed in a way that allows them to be ingested.
Intermediate and high risk MF has a high mortality rate and short life expectancy. What Phil from seeking Alpha had said was only 2 died while on Imetelstat and one of those was atributed to Imetelstat dosing and lead to changes that labs now point to when dosing should be held.
The hypothesis is that solid tumors contain a mixture of mutated cells most cells use the telomerase pathway while some use the ALT pathway. When one targets Telomerase without targeting ALT then those ALT cells multiply and fill the void. The other hypothesis is that long term exposure to telomerase inhibitors give rise to ALT mutant strains of Cancer. When Imetelstat is combined with the PARP inhibitor 3AB it works faster and no ALT mutations develop. The other combination is Imetelstat with CDKN1A targeted therapies from the Yale/UCDavis study. That showed un believable results in solid tumor cell lines.
There is no agreement not to persue ET and PV. There is no FDA hold on those indications because it was removed. The company does not want to persue those indications because cheap alternatives exist in those indications. CALR ET might become a target for Imetelstat because they are high risk.
Baker Brothers bought shares in Geron aft ASH ET data back in 2012 at $1.69 average. They recieved AST shares and BTX warrants from their Geron holdings.
His departure from BOD was put out and he is not leaving until May when a replacement is appointed to the BOD.
he always floats the reliable source statement and rumor has it statment with his false statements ment to scare people he is and aways will be a low life.
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irish good to see that everythin is well google Sergei Gryaznov: The Interview click the lower left corner on the pop up Gryaznov is the one who put the lipid backbone into GRN163 creating GRN163L Imetelstat. The interview is insightful.
To make sure they have early readout markers that are actionable for acceleration tward early approval. They want to insure the tial is designed so they can push for breakthrough designation and fas track.
They are going to start a multi center confirmatory phase 2 trial they have already had an exploratory single center phase 2 a 20% rate of PR or CR in an indicationthat no drug has had any PRs or CRs in. The numers you are quoting on percetages do not factor in 20% PR/CR rte for MF a 97% CR/PR rate for ET. CALR ET that takes 3 years to atain CRs with Interferon Alpha takes just 6 weeks on average to atain CRs. The phae 2 MF multicenter trial will start in June the single center phase 2 trial at Mayo is still running right now.