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leifsmith

01/31/14 10:26 AM

#79410 RE: davidc2 #79409

You just found out about the need for multiple species in tox testing.

What makes you think the company didn't know it already?
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daBoze

01/31/14 10:38 AM

#79416 RE: davidc2 #79409

I believe it's disingenuous to think that experienced doctors and researchers did not know from early on what tests had to be run. Certainly they did, and they are being scheduled in accordance with the overall development schedule.
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ZincFinger

01/31/14 10:52 AM

#79422 RE: davidc2 #79409

"They" are not just now discovering it. WE are. They have had to wait until the drug was clearly in it's final form to begin the construction facility. That is ALWAYS the case with biotechs.

The pattern here appears to be that when YOU learn something that others have known all along you assume that no one else knew it either. I don't think you're going to get very far with that approach.

THEY have always known about these things and have taken them fully into account.
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KMBJN

01/31/14 10:54 AM

#79423 RE: davidc2 #79409

"They've done over 5000 animal studies since 2005 and they're just figuring out now that they need to do cross species animal testing."

No, wrong. Poor speculation on your part.

"They wait from 2005 until 2012 to decide that they need to build a newly constructed manufacturing facility to be able to proceed into tox?"

Wrong again. They are not waiting for new facility to do tox. They are producing tox material in existing facility.

I think the main reason why tox wasn't done in a more timely fashion was they were short of funds, but also they say back-order of equipment and lack of qualified employees (which having funds may have solved if they were available back then), not to mention they found out FluCide is very non-toxic, so they need lots of FluCide for tox testing (which of course takes time to produce). Perhaps they also had other priorities, like finalizing the version of FluCide to take into tox/trials, building the rest of the pipeline (oral FluCide, HIVCide, DengueCide, CoronaCide (MERS), etc...), doing more pre-clinical work (different strains of flu for FluCIDE), raising money, etc...

I share the frustration with the apparent slow progress on tox testing, facility build-out, and start of clinical trials, but the goal is to be done with tox by 3Q and into humans 4Q or 1Q 2015, and I'm pretty sure they will make it. I wish they would communicate the reasons tox testing hasn't started yet, but maybe we just need to learn to be patient, since the reward should be huge.