If only it were an immunologic Pill- wow.
Theoretical "Problem" (that never was shown to exist clinically) Solved. These patients are constantly getting levels checked anyway, so IF antirhupH20 antibodies get to a certain predetermined level- give them an "SC Holiday" until they are down.
lung cancer w inhaled insulins? MNKD doing long follow up study just in case cause unknown.
Afrezza- pure convenience - oral vs injection analogous to sc 1x a month vs sc 20 x a month or IV- plenty of other insulins- approved.
Look at Hantson and Frost guidance and sleep well longs.
From Baxter Briefing Book- shows immediate marketing advantage not only over IV IG's but over other SC.
The only kicker is that there is an "industry representative" from BAX Competitor CSL Behring on ADCOM Roster- must be recusing from the voting.
Safe and Convenient- "Conventional IGSC (Behring) can require up to 20 injection sites per month, versus
approximately 1-2 for HyQvia" BAX Briefing book
RhupH20 is Enhanze and Hylenex so ADCOM will postively effect New Diabetes Label for Hylenex !
It's so easy to go on the Blood Product FDA site - click on ADCOM materials 2014 and read it all- as I did- or skim with the table of contents- going to the well marked conclusion sections. Simple and delightful- BAX with HALO's Help built a brick wall with almost no holes. They even timed AE's to see if they occurred before or after the appearance of titers- No Difference. No More AE's in those with titers in GI, Neuro, Allergy, Local Adv Effect. A Total Home Run.
HyQvia is the combination of 2 FDA Approved Meds- Frost Before he left and Hantson- Baxter Bio CEO- both guided an ADCOM victory. Makes sense- Nonneutralizing antipH20 antibodies are found prior to 1st rhuph20 exposure because pH20 exposure is common in a sexually active society in which acrosomal (head of the spermatozoa) enzyme is shared readily. If the FDA Bans HyQvis- what''s Next?
Apparent;ly Bashers have trouble finding posts on the exact topic they are looking for on the board when it doesn't bash....
1. 3 yr Study + over 1 yr in Europe with LOWER percentage of Adverse effects than IVIG- Per JPM.
2. Hylenex IS Enhanze and is FDA approved for an unlimited number of injections- IG is too- so Both components of HyQvia are FDA approved- You have to be pretty DUMB to short this event.
3. Q2 BAX CC- Hantson takes you by the hand and walks you to a positive ADCOM.
$. Frost sais before he left all the CRL questions were answered, BAX added som more followuo belt and suspenders data and Hantson recently confirmed the SAME 4 questions ("why is this night different....?") were the only questions the FDA had for Baxter.
Done and Done
We heard about RN-316 on an earnings call.
From Ludwig Hantson Pres BAX Bioscience -
"Our Data is Clean-we have a Positive benefit risk-we’ll have a Great dialogue with the FDA."
"still same 4 Questions on long term safety of pH20 Abs specific to neuronal development & fertility -nothing new" since CR Frost and Hantson both have said all of these questions have been successfully answered.
the same strategy for Mabthera was highlighted by o'day pres at Roche
Edison Inv Research 7/3/14- "We expect Baxter to receive HyQvia’s US appvl in 2014 & HALO could receive up to $30M in future milestone payments" They also estimate a $500M peak sale total for HyQvia.