Mike Havrilla

BioMed News Bytes: Arena, ImmunoCellular, YM Bio

I think VVUS has emerged as the front runner with ARNA / OREX both chasing. Will now be interesting to watch the deal flow for this trio of weight loss / obesity plays as they prepare for FDA submissions. Only wish I had more spare cash to invest in VVUS back in March when it was around 3 bucks:
seekingalpha.com/artic...

FDA and Clinical Trial Updates: Weight Loss, Diabetes and More

thanks for the info but I just run and lift weights to stay in shape instead of using OTC diet drugs


On May 15 08:22 AM Cynthia wrote:

> If you have been or are currently using Hydroxycut supplements to
> diet or get in shape, you should know it's been recalled and is apparently
> very dangerous. This site has a lot of good information on its problems:
> www.hydroxycut-liver-d.../
>

Pending Clinical Trial Results: Ten Extreme Trades

Dan,

My focus is to provide info on FDA, clinical trials, and emerging small/micro-cap stocks. I am not focused on recommending stocks or tracking portfolios -- just tracking all of the info so investors/traders have a source for new ideas and pending results/decisions.

Mike


On May 14 10:53 AM Norwell wrote:

> Hi,
>
> I was wondering if there is a log of your 'portfolio' performance
> somewhere? The area of micro-bio's exploding seems interesting. I
> just can't tell if there is any logical (repeatable) approach that
> may work towards an alpha return.
>
> Dan

Vivus: A Bet on Well-Funded, Late-Stage Pipeline

Biotechs_Maven, check out my new website at BioMedReports.com -- we are looking for contributors on the site so email me if you are interested, Mike


On Mar 04 07:05 AM Biotechs_Maven wrote:

> Take a look at VVUS Phase 2 trial.At that time they actually use
> the same Generic Topiramate 100mg dose and Generic Phentermine dose
> too.They even do not bother to mix the two drug into one tablet at
> all.But the way they dose it was,
> they give one drug in the morning and the other in the afternoon.
>
> Only from Phase 3 that they change the formulation slightly, that
> because They need to make it different then the Generic formulation.
>
> That show if the Phase 2 trial is doing just fine with generic dose,
> then most people will buy the generic Topiramate and Phentermine
> dose and use it just like the way VVUS use it in their Phase 2 trial.
>
>
> also Topiramate had received FDA warning on 2001, that it might cause
> adverse event to the eye, and just few months ago, receive another
> FDA warning that Topiramate could cause 1 out of 500 patients with
> Suicide thought.
>
> This same Suicide thought was the one that make Acomplia (another
> diet drug) do not get approved by FDA, and later Acomplia even get
> pulled back from European market where it were already approved.
>
>
> Plus the fact that from Qnexa Diabetic 1 year trial, it is shown
> that Qnexa start to loss efficacy after only 28weeks of use, and
> then at week 44, the arm taking Qnexa actually start to GAIN Weight
> instead.
>
> The Insider also had been selling lot of shares lately, in fact the
> CEO of VVUS is selling his shares the same day as VVUS R&D day.
> So during that day while VVUS is presenting the result of Qnexa Phase
> 3 Equate trial, VVUS CEO is selling his shares,
> and had been selling more then $2.5million worth of VVUS shares for
> the last 18months.
> and the insider that is selling is not limited to only VVUS CEO but
> many other insider also sell.
>
> There is no doubt that Qnexa have decent efficacy, but efficacy alone
> is not enough to guarantee approval of Qnexa.
>
> VVUS share price also had been trending down this past few months
> after the result of Equate phase 3 study (a short 6months study with
> not large patients involved).
>
> so maybe VVUS is a good short term play, but before you decide your
> self for long term hold on VVUS, you got to do more due dilligence
> on the data itself.
>
> My bet is on ARNA instead, because ARNA is brand new drug (not generic
> combo), and management of ARNA mostly buying shares or holding to
> ARNA shares, (very dismal selling).
> ARNA also had enough money to last until NDA on early 2010,
> and the CEO of ARNA even decide to pay up the convertible holder
> with CASH instead of diluting shareholder by paying with shares.That
> show ARNA is very confident with the result of Lorcaserin.ARNA also
> enrolled more then 7100 patients in their Two Phase 3 trial, far
> larger then VVUS or OREX Phase 3 study.
> and their First Phase 3 trial is a 2 year trial, so this should satisfy
> the FDA about Lorcaserin long term use.
>
> Disclosure: I holds a LONG positions in ARNA