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chumppunk

02/01/19 6:39 AM

#34703 RE: trding #34702

Trading- now let’s move the needle.
Chump
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weasel6667

02/01/19 6:42 AM

#34704 RE: trding #34702

Based on this huge step forward from the FDA, I am wondering how fast the BLA will be processed by the FDA
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Amatuer17

02/01/19 7:45 AM

#34707 RE: trding #34702

This is a good move - the confirmation of 700 mg dosing - it eliminates the unnecessary failures and keep safety at same level.

Also this will allow them to use that dosing for TNBC - I hope they do not start with 525 mg.
700 mg gives same safety and has high occupancy with CCR5 - it could block the movement of TNC

This news also shows that they are still doing dose optimization for mono @ 700 mg - that means pivotal mono trial will not start for some time
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goldenisla

02/01/19 8:10 AM

#34708 RE: trding #34702

Talking to distributers? Increasing inventory of their product?

NP wants to go it alone. BP must not be offering a deal he likes.
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gestalt2

02/01/19 8:47 AM

#34720 RE: trding #34702

I have a theory as to why they aggressively produced inventory and continue to do so. It seems from the wording that they are negotiating deferred payment for distribution and I think this is possible because they are using the inventory value as an asset to ensure payment. The cost to produce the drug is a fraction of its end use value so they are basically taking the investment and multiplying its size and value by building an inventory. The amount of upfront payment they get is based on the value of the inventory, not its cost to produce. If we just sat on the cash raised and used it for trials there is no value until product is sold, with inventory the product has value now, assuming fda approval. The increase in the selling price of the drug supports this.

I was also not aware that this 700mg safety acceptance was even part of the discussion with the fda. I thought the safety arm was done. It is good news and will pay off in future indications for sure but it is not the mono trial protocol approved type pr. I think I’m being a little negative about this but it seems like this is a slow grind progress with new steps of accomplishments instead of the accomplishments we have been hoping for.
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finesand

02/01/19 10:29 AM

#34738 RE: trding #34702

trding - GOOD MORNING

just arrived home, seeing this (o8>

WOW, now slowly reading and buying a bit more (o8>
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finesand

02/01/19 10:34 AM

#34740 RE: trding #34702

trding - this is THE NEWS

I ignored the whole financing BS going and just bought 51c lol