HGSI : ARE YOU REALLY SURE ABOUT BENLYSTA APPROVAL? WHY?
WS' SEVERAL ANALYSTS CRAZY ABOUT BENLYSTA'S APPROVAL: HOW IS IT POSSIBLE TO TURN THE TRUTH?
I hope in Benlysta's approval only for the Lupus' Patients' benefits, not for other matters: analysts, shareholders,
speculators, longs and shorts,losses and profits come after lupus
patients lives. But i'm now very sceptic (hope I'm wrong) and
find no real transparent information on some message boards or by analysts.
I was willing to invest hard in Human Genome before reading
some conclusions of the briefing documents and the press
releases, because of great hype on benlysta and safety assurance
by analysts, but I'm neutral now, sitting and waiting...
Fda's staff conclusion seems not too much favorable for positive
benlysta's outcome, but numerous analysts said the "low" risk-
benefits ratio allows approval, the briefing documents cleared
the pathway for multibillionaire use of 1st new lupus drug in
fifty years!!! Did you read some of the Fda's staff conclusions?
I've read something and I'm scary now. 38,50,100$ for HGSI?
More likely 2-3$ and 2-3 years more of studies and tons of
safety and effectiveness data to be produced...Friday's FDA's briefing documents are the basis for next tuesday panel's discussions, any hypothetic positive majority votes will need to win a lot of safety and efficacy hurdles in 9 december real test...and this vote is not "written in the stone" and will not tie fda final decision. Keep in mind this, avoid to lose money, my advice is waiting for final decision due in december before investing in HGSI.
BENLYSTA MAY LIKELY NOT BE APPROVED, BASED ON BRIEFING DOCUMENTS, IMHO MAY RECEIVE A CRL (requesting new efficacy data, safety database, detailed risk mitigation plan) ALLOWING PERHAPS FUTURE APPROVAL CHANCES,PENDING POSITIVE NEW CLINICAL DATA, OR MAY BE A ONLY A COMPASSIONATE USE DRUG, AS INSMED'IPLEX FOR ALS PATIENTS IN ITALY!!!
Remember: 3 completed suicides in 2 trials (2 happened during taking benlysta, one during the follow up period) + 4 suicides attempts (2 during taking benlysta,due during follow up, need to monitor safety and patients reaction)
Key words from Fda's staff:"The robustness and the clinical meaning of efficacy findings warrant discussion"
Hgsi enourmous pps is one of the biggest speculation above
lupus poor patients'lives, they deserve better options than
current, but Benlysta (an injectable product, also known as
belimumab, a monoclonal antibody) approval maybe sadly
unlikely.
Put in your mind that effectivness and safety of Benlysta is all
to be assessed, a very tough pathway. Investors and analysts are
not scientists, their conclusions are merely speculative when
data are mixed and not supportive. YOU all are forgetting that
investing making money is risky and almost impossible, but
obtaining Fda's approval much more.
The following points what I understand reading the FDA's staff
conclusions (I'm not a phisician or a professional investor, trying to become only a careful reader, according to my intellectual limits) and not the ilarious price target by pumpers paid analysts...with all respect for them but no one saying investing at these prices in HGSI you may lose all money.
1)Benlysta may not be safe based on clinical trial data
(infections, malignancy,deaths,cancers, suicides, depressions)
after "serendipity" or chance findings...7 between completed and
attempted suicides (3 completed and 4 by tentative or idea),
several adverse reactions or Serious Adverse Events
(depression) in those taking belimumab groups (much more
than in those taking placebo) other psychiatric events not
classified as SAE more frequent in those taking benlysta than
those taking placebo (depressions mood).Even if Benlysta use may not be proven the biological cause of suicide or other psychiatric serious and not serious adverse events, even if suicide and depression are potential consequences of lupus status, Human Genome perhaps didnt'explain in the filed BLA how to treat or prevent these dangerous potential events and it seems they didn't realize the lethal effects of belimumab (suicides) or did they "hide" those events, perhaps normal in lupus patients? Did you know about 3 completed suicides? I didn't know and too the FDA.
2)Benlysta may not be effective based on clinical trial data
("lack of robustness" or low significance) as shown by data, the
largest interested group of patients, the afroamericans, not very
benefiting from benlysta use, as follow up study shown,
benlysta loses all its efficacy after 76 weeks, therefore, works as a placebo. A test score measuring symptoms shown improved
conditions in lupus patients taking benlysta for a year, but
vanishing overtime (after 76 weeks).
3)FDA shocking conclusions: "lack of demonstrated efficacy in
black patients" (most hit populations segment); "inconsistent
efficacy trend across different geographical regions of the
world"; "The robustness and the clinical meaning of efficacy
findings warrant discussion".
4)Only the need of a new therapy, although partially effective
and with cleared potentially lethal side effects, may be the
reason of an approval (imho unlikely). Will be it full, partial, or with a big black box warning? Or only for "compassionate use",
while testing new patients for years and years and burning cash
and diluting shareholders?
5)Current therapies for lupus, although not specifically initially indicated for lupus (such as prednisone steroid, or an
immunosuppressant by Roche, some antimalarials and
cyclophosphamide based chemotherapy) produce significant
side effects in the long term, as Lupus foundation President also
said, "they are worse than disease"...such as hypertension,
infections, anemia, hair loss, diarrhea, infertility, stroke and
heart attacks, but not suicide and cancer. Perhaps the
suicide instict but not the completed materialized suicide
itself!!! Even if lupus patients may be subjected to
suicides...benlysta groups shows higher rate of SAEs and
suicides than placebo; 12 patients died taking benlysta (3 for
suicide), only 3 taking placebo (no one for suicide)!!! Partial or marginal efficacy as evidenced by released data means that fda
will concentrate itself on safety!!! Higher mortality risk in
belimumab groups than in placebo patients is a fact, more data
needed, efficacy not proven, safety isseues higher in benlysta
than placebo, therefore outcome in december may be likely a
CRL and new clinical trials requests.
6)Lupus treatment Benlysta seems not working at the same way
for all patients; Fda found african americans faring worse after
taking benlysta(different efficacy in different groups, it seems
working better in southamerican than northamericans, FDA
doesn't trust with all respect indian' or mexican's data more
than us based data!!!).
7)Even if AdvisoryCommitteee gives green light on Benlysta
(unlikely), Fda may not follow their opinion (very likely) and
will ask for new trials.
8)Lupus patients suffer a lot of inflammatory disorders such as
skin rashes, kidney inflammation, muscle and joint pain, heart
and chest pain. Benlysta's partial and time-limited efficacy and
proven and still uncertain magnitudo side effects perhaps worse
than those lupus symptoms, overtime.
9)If I were the FDA, and sceptic about Benlysta's effectiveness
and safety profile I would recommend new larger trials, but
allowing the compassionate use, when applicable, when all
other approved treatments failed.
10) Are you really sure that the most conservative agency in the
world, hit hard by Lipobay Vioxx and Erbitux scandals and
control's inefficiency, will give green light to not 100% safe
Belimumab? Fda will not risk their reputation and will ask for
new trials, imho. I'm sorry for all lupus patients, hit hard by
recent Roche's Rituxan failure Genelabs'Prestara and LaJolla's
Riquent found futile, they are the only victims here, not naive
speculators and long investors and analysts giving total faith to
a drug without reading the posted documents.
