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2019-02-01 BOOM, CYDY has FDA blessing for HIV-1 Combo + Mono and more..
- This is a wall breaking event in our view..
- FDA prompted by 700mg Monotherapy results to avoid delays: Move all CD02 Combotherapy patients to (new) pivotal Monotherapy
-- 700mg Pivotal Monotherapy won’t start from scratch but now has
--- 45 pts 700mg enrolled
--- 29 pts switching to 700mg higher dosage
--- 40 pts currently in screening to initiate 700mg
--- Subtotal: 114 pts
--- FDA also allows all ongoing pts to upgrade to 700mg
--- Subtotal: Over 150 pts?
-- FDA also accepts safety data for Combotherapy BLA approval from 100 pts on 700mg on the Monotherapy trial. This will also be used for the Monotherapy, which is an sBLA label extension.

-- CYDY is in negotiations for partnership, distributing PRO 140.
--- Non-dilutive upfront investment pre-approval in CYDY for post-approval royalties.
--- Adding $500M worth of inventory by manufacturers for deferred payment post-approval
-- Above partnership structure implies that financing could be completed now, investors would need to buy at the market if signed.

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