I believe the issues with gvhd They did enroll
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Posted On: 11/29/2019 10:01:35 AM
I believe the issues with gvhd
They did enroll 10 patients randomly 350mg vs placebo a couple years ago. They have since modified the protocol for 700mg. So I suspect 350mg wasn't enough and they have had a hard time to come up with the money to get the BLA (including current mono trial) done. So adding this cost, in-addition, was not a priority until they have better financing.
tnbc is different if a couple more patients have similar results as patient 1, then they might get btd, which changes the outlook of the entire company.
nash was different also, animal study cost little, but the possibility of partnership or other positive potential greatly outweighed that trial cost. So they are aiming at low hanging fruit with the little extra money they came up with.
Big picture, all imo, they have had to raise 50M the last two years selling shares. About half of those shares are held, the other half sold, around $25M. With 253 trading days, that equates to $100k per day, more than the public stock trading has been able to handle, putting great pressure on the share price. They could have probably taken a 80/20 split much early phase 2, but they wanted a better 50/50 split, normally only seen at end of phase 3. The FDA adding requirements to HIV have put them in a place to take a worse than 50/50 deal or dilute selling shares. They have choice the latter until now. But having tnbc and nash p2 trials helps their odds.
They did enroll 10 patients randomly 350mg vs placebo a couple years ago. They have since modified the protocol for 700mg. So I suspect 350mg wasn't enough and they have had a hard time to come up with the money to get the BLA (including current mono trial) done. So adding this cost, in-addition, was not a priority until they have better financing.
tnbc is different if a couple more patients have similar results as patient 1, then they might get btd, which changes the outlook of the entire company.
nash was different also, animal study cost little, but the possibility of partnership or other positive potential greatly outweighed that trial cost. So they are aiming at low hanging fruit with the little extra money they came up with.
Big picture, all imo, they have had to raise 50M the last two years selling shares. About half of those shares are held, the other half sold, around $25M. With 253 trading days, that equates to $100k per day, more than the public stock trading has been able to handle, putting great pressure on the share price. They could have probably taken a 80/20 split much early phase 2, but they wanted a better 50/50 split, normally only seen at end of phase 3. The FDA adding requirements to HIV have put them in a place to take a worse than 50/50 deal or dilute selling shares. They have choice the latter until now. But having tnbc and nash p2 trials helps their odds.
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