Biotech Values

[jq1234]

>> The FDA may/will be forced to remove the clinical hold on the TKM_Ebola trials sooner than later?

No, I don't think so. Ebola related drug INDs are developed under animal rule. I don't think they'd relax the minimum required ph1 studies in healthy volunteers. Clinical hold will be removed once TKMR submits requested information.

Given past issues with clinical trials from experimental drugs in Africa, I don't think any regulatory authorities would rush to approve drugs that have not proven at least safe in human for current Ebola breakout.

Here is a good article on the situation:

This should be the last Ebola outbreak without a treatment, Canadian expert says

.................

But Kobinger agreed with others in his field who have argued that it would be unwise to use these untested tools this time, saying the Ebola vaccines and drugs must go through Phase 1 clinical trials in people before they could be used in an outbreak setting. Phase 1 trials involve giving a drug or vaccine to a small number of healthy adult volunteers to ensure that it is safe for human use.

"These are all experimental drugs that have not met the requirements ... even for a Phase 1 (trial) right now in humans. So they have to pass all the toxicity (tests), they have to pass the safety trials," he said.

http://www.winnipegfreepress.com/arts-and-life/life/home_family/this-should-be-the-last-ebola-outbreak-without-a-treatment-canadian-expert-says-267994261.html


>> TKMR's chances of getting recurring revenues every year for the stockpiling of the Ebola vaccine just went up significantly?

Yes, I think so.