Is Gajanan Bhat (ODAC failure reason) not fired yet!

Ok, you are trying to use “data” to prove your point. No one is going to contact these people nor would any of them speak about Spectrum. Each signed a separation agreement that legally prohibits them.

I know each of these people and the stories you allude to. You have a shred of truth in here, but it’s largely incorrect.

In other posts, you speak of clinical trial data and information that can be found by researching on the internet. I’ve tried. It’s not there. If it is, post it.

I wish you’d learn to write. Embarrassing.

 

Oh! So this is how Gajanan was hired. NO Doubt, I worked briefly with him from clinical operations side and I knew straight away that Gajanan Bhat is good for nothing since I worked with him on Apaziquone ODAC and was annoyed by him because he stressed so hard on Apaziquone submission while the trial had failed miserably and even a child would tell you it won't get approved. He still convinced everybody including then CEO Raj Shrotriya that he can do magic and get it approved.

Gajanan's Magic costed spectrum $3 million in FDA filings and a huge failure in ODAC for the drug Apaziuone/Qapzola with FDA slapping us all 14/0 votes against us. This knewsnis all over internet. The only thing which is saving Gajanan is that he is Indian and SPPI favors Indians over bright local Americans due to SPPIs Indian. Now after this if any company wants to keep him or hire him that is up to the risk appetite of that company.

 

Is that Chris guy in hr still around. He is very deceiving.

 

Yeah! Pretty much correct. If Gajanan will be doing data theatrics on ROLONTIS then, a CRL or a possible rejection is very much expected looking back Gajanan's negative repo at FDA.

Tom or Joe needs to work out with few industry veterans on ROLONTIS or probably a strong Biometric Head above Gajanan. Someone who got 30+ years of Biostat/Biometric experience at VP level. ROLONTIS can't be left upon naive & stupid kids like Gajanan Bhat; so far so data is concerned.

 

I am mighty surprise that joker's like Anil Hiteshi and Gajanan Bhat are still in the company. What conspiracy are they up to against JT? Heard Anil is still meeting his ex-boss Raj and taking orders....

 

Anil and Gajanan both badmouth JT and Tom day and night but fools them by bowing down when they come face2face. Anil & Gajanan both are making fun and fool of JT&Tom R all the time.

 

Will Gajanan B the one working on pre- BLA meeting on Rolontis with FDA. If yes, I am super worried now. I still can't forget how FDA slapped SPPI 14-0 votes in ODAC for Qapzola. Gajanan was the Biostatistician who cooked that data. It got then CEO Raj fired from SPPI.

 

Well, Regulatory authorities are sharp enough to know about Gajanan and his bad reputation. They must be already convinced on how SPPI is pumping news about ADVANCE trial of ROLONTIS compund and saying nothing about the parallel failed Trial RECOVER of ROLONTIS. ROLOTIS is way inferior then NUELASTA. A good analyst will know this in moment.

Gajanan's catastrophic failure in ODAC in 2016 on the drug Eoquin/Qapzola/Apaziquone is a live proof of his abilities. SPPI lost this ODAC review with 14 - 0 votes. Not even a single vote on their side. This proves data manipulation is not statistics and SPPI should learn this.

Having a guy like Gajanan Bhat doing statistics is a true shame for SPPI.

 

Do we still have the joker duo Anil H and Gajanan B working on Rolontis FDA submissions! Aren't new CEO of spectrum able to find any credible guys to submit ROLONTIS data. Above two individuals have an extremely bad repo in FDA. SPPI needs to replace these two asap and else there will be only a CRL for Rolontis.

 

Doesn't matter whether SPPI shady Regulatory Head Anil H and ODAC failire Data Management head Gajanan B fake data or do something else!

Game is already changed after FDA last week approved Biosimmilar from Mylan+Biocon. Coherus has also worked on their Biosimmilar and looking good for approval. Apart from that I myself working on 5 such biosimmliar from CMC part and all are on their way for approval within next 12-18 months so once market share is divided SPPI will be fighting hard for even a $40 mil market share alongside everybody. Too many Biosimmilar and Generics will fight for the spot while AMGEN will still lead the pack with proven and ORIGINAL NEULASTA.
Somebody will have to come with a drug better drug then nuelasta if one seek a chance. Any advantage which was there 2 years ago is gone now!!

But First, SPPI will have fire existing bad line of VPs and hire some experienced veterans for FDA submissions & dialouges. If they seek any chance of even getting a CRL. Road is tough ahead and their weak manpower specially top brass indians hired through Nepotism will have to go away to make way for more experienced industry professionals.

All will depend which way existing COO Tom and CEO JT will play. Will they do just like what previous CEO Raj did or, they will try to be ingenous. Success or failure will all depend on their choice of manpower. Will they take ODAC failures with them or will they change them.

 

Many eyebrows raised after Gajanan and few others presented Non-Inferiority and jokingly some Suprerirority data about ROLONTIS (eflapegrastim) vs. Neulasta (Pegfilgrastim) in Austria last week.

https://seekingalpha.com/article/4185116-spectrum-pharmaceuticals-sppi-annual-meeting-supportive-care-cancer-slideshow

Few great oncologists were there who actually worked on real drug NUELASTA of AMGEN which is a great drug and SPPIs knockoff version is no match to NUELASTA. After the presentation people winked a lot to each other. Gajanan looked like an Idiot while presenting some numbers.

Next time it will be better if SPPI send some experienced Biostatistician to such meetings rather than multiple ODAC failed Biostatistician.

 

It's simple, rather than trusting one site investigators only words.. FDA should put a rigorous audit on each and every site which was involved in ph-2,3 Rolontis trials to find out the reality on actual efficacy and safety including AEs and Neutropenia responses on Rolontis vs Nuelasta.
This will actually clear out any doubts, dirt or any fabrication if done with the trials or data. Gajanan should propose for an extensive audit by himself if he is clean but if he is not he will refrain to even talk about it.

 

Spoke to Gajanan today over phone...he is pissed that Tom Riga is forcing him on Rolontis data. Then he said, both
JT and Tom are idiots like Raj and he knows how to handle them as well.

 

Oh man! After reading below analysis/article from a bunch of reputed Doctors and MDs it's confusing whether SPPI's ODAC Failed Shady Biostat Lead Gajanan Bhat is lying or, these doctors alike Bob are wrong!

After all, a bunch of Doctors can't be wrong after complete medical review of near term catayst/drugs Rolontis & Poziotinib.

Read the complete article below scratch-to-finish & try to understand it scintifically or, ask a real scietific guy to expmain you nd then you will be able to know/decide yourself...what's the truth on these drugs?

https://seekingalpha.com/article/4204232-spectrum-pharmaceuticals-buy-sell-september-data

 

Surprised Anil and Gajanan are still in SPPI after all this. Both are super cunning and must have done something to fool JT and Tom Riga.

 

Today SPPI ticker showed $16.42. couple of days ago it was $21.92. What happened?

Why don't SPPI throw out bad apples like above two and hire some really good Biostat and Regulatory guys to win market trust. SPPI needs reputed industry folks on these positions. I thought new CEO is from AMGEN and I had great respect for him but it's cynical to see that he is carrying on with above Jokers as Regulatory Head and Biostat Head.

 

Are we going to use third party for data verification of Rolontis or confident of Gajanan's data analysis capability? Are we gearing for another ODAC failure

 

Failures are irrepressible until change happens within and a reputed industry Biostatistician joins us. Someone who has a hold on his subject and someone who is well respected in FDA and other regulatory agency instead of having an ODAC failure tag.

 

I heard a news will be afloat in couple of days to make stock look good. What could be good? How Objective Response Rate of so called wonder drug POZIOTINIBd dropped from 67% to 58% and then ultimately only to 43%

Do anyone know how to do statistics here? Name a good statistician lead you have Spectrum?

 

Spectrum Pharmaceuticals to Present Corporate Update at the 2018 Cantor Global Healthcare Conference on October 2 ?

Any news what's going to be presented. It will be interesting to see what SPPI management says ?