OB:

Putting it in risk-reward terms might help to clarify:

What is the risk if they get a CRL? $10-12?

What is the potential gain? $35?

There is also the possibility of approval with a restrictive label, in which case we could drop to $20 or below.

Risk-reward seems to be even or a little on the risk side...you could lose or gain ~50%.

That said, I'm playing options on the positive side, with a few protective puts.

Good luck!

You're well on your way to "The 12 Stocks of Christmas":

5 GOLD 'N MINERAL STOCKS
4 Bios that start with "A"
3 Gaming stocks
TOO many Bios to count
And a Financial, as well!

:)

Happy Holidays!

lol...not me.

I couldn't remember what was due to be reported near-term.

The link to the article reminded me of the 1-year MDS survival data.

Thanks...

What are the catalysts for Cyclacel for the next several months?

TIA

Thanks for the info, ou71764.

Thanks, ou71764:

At what point can the preferred S/H demand payment on the dividends and/or conversion to shares?

I just want to understand the timing, and whether this could force CYCC into a bad deal in the near-term.

They seem to have enough money to get a start on the ph3 trial or pay off the preferreds, but not both.

Can anyone explain the full situation with the preferred shares, i.e. number, terms, dividend due, 2 new board members and timing of the terms?

TIA

If this were an FDA cancer panel, vote would be 12-2 against. But this same panel had a tie vote for keeping Meridia alive??? There's a shot for a positive panel.

ALXA: Any news? 800k shares in last 15 mins, after 250k this morning. Disclosure: long.

hptaxis:

Thanks for the info.

Could be a short on any major move up?

MNKD:

Recently re-filed their Afrezza (inhaled insulin) NDA.


Anyone here care to handicap their chances of:

- Getting FDA approval on Afrezza by the end of the year.

- Signing a deal on Afrezza before FDA review (they need money)

- Whether Afrezza, if approved, will go the way of Exubera (pulled from market by Pfizer after marketing failure)


No position, but taking a closer look.

TIA

Isn't this what Sanofi-Aventis has been saying as well, up to and including the time of the MNTA M-Enoxaparin approval??

I wonder what the FDA would have done with the TEVA/Amphastar applications if Momenta hadn't come along with its application (as well as helping to resolve the heparin contamination)?

Would the FDA have approved one or both of their applications by now? That is, would the FDA have realized that their products were inferior to Lovenox without Momenta's ability to fully characterize Lovenox?

PS: Thanks, Dew, for your coverage/analysis of MNTA! Helped me tremendously in my brokerage account.

[MNTA] Options expiry today?

Exactly...I just couldn't recall if we had ever heard this from Momenta directly.

Thanks

MNTA:

I can't recall if this discussion was put to bed, but when talking about the M-Enoxaparin multiple generics scenario, Shea said something to the effect of "In the case of other interchangeable generics, Momenta would receive a high single or low double digit royalty".

In other words, the discussion of substitutible vs non-substituble Lovenox in the case of Teva and other competitors is very pertinent to Momenta's partnership agreement with Sandoz/Novartis.

Your changes make sense.

The options are WAGs, but results will be interesting as many on this board follow MNTA.

MNTA: With all the speculation, seems like 2 surveys are in order (Dew?):


When will MNTA's M-enoxaparin get approved:
- 1H '10
- 2H '10
- 2011 (gives rkrw a full year to dream up another April Fool's joke)
- Never


Who will be MNTA's competitors for M-enoxaparin:
- Another generic will be approved before MNTA's
- MNTA sole generic, no authorized generic
- MNTA sole generic, SNY introduces authorized generic soon after
- Multiple generics, no authorized generic
- Multiple generics, SNY introduces authorized generic

"on our extensive characterization technology invented by nerds at MIT we plan to charge a premium to branded enoxaparin"

April fools???

Still, this article does convey some apparent new information as to why Amphastar believes they are not being treated fairly:

Very heavy here in Westminster.

[OT] Senate Health Bill;

Maybe even Doctors and Hospitals?

Throw in dentists and trial lawyers, too, and we might have a bill worth signing. A healthy smile and free legal care are rights, too! :)

MNTA - Shelf reg.

Maybe they DO intend to go alone on M-118? Or at least posture that way for negotiations.

What is the estimate on how much it would cost to run a phase 2b and phase 3 on M-118?

[OT] In that no black helicopters were reported, I think we can safely assume this story is patently false!

MNTA:

A few quotes from the CC (transcript on seekingalpha):

Generic Lovenox

The M-Enoxaparin ANDA continues to be under reviewed [appropriate slip in transcription, lol] by the FDA, and we remain cautiously optimistic that 2009 approval is possible. Should an approval be granted, we have large supply available and we and Sandoz intend to launch as soon as possible following the FDA’s decision.

At this point our heparin suppliers and API manufacturer have been inspected with no significant issues identified to us. However, we have not yet received the final inspection reports and the questions could be asked at any time.

In short, we remain confident in the approvability of M-Enoxaparin and we believe the FDA has all the major elements it needs to approve the ANDA. While we believe it is possible to receive an approval in 2009, there is no statutory timetable for an FDA decision, so the ultimate timing of the decision remains uncertain.


M118

As we’ve discussed in the past, we are actively seeking a collaboration partner to finance and support further clinical development of M118. We are continuing discussions with multiple potential partners, but do not anticipate entering into a partnership before year-end. [This quarter doesn't look good for a deal. Perhaps Q1?]

$107.3M is sufficient to cover operating expenses
for more than two years.

Which begs the question, why do the recent financing?

1. Get the cash when the market is hot, coupled with uncertainty of when generic Lovenox will be approved and whether Momenta/NVS will have the sole generic
2. Don't expect to partner M118 soon.
3. Maximize M118 royalty by taking less upfront/milestones
4. Start & complete Phase 2b(?) before partnering to maximize deal, as offers are coming in low for M118
5. M&A
6. Other

#1 seems the most likely, but underlying this is the feeling that MNTA doesn't expect to partner M118 anytime soon. Your thoughts?

ARNA - positive data

http://finance.yahoo.com/news/Positive-Data-from-Arena-prnews-2665863508.html?x=0&.v=1

XMRV retrovirus: A follow-up research question: Is the mechanism of transmission similar to HIV, since it is also a retrovirus?

I consider the Kaiser findings most relevant for the general population rather than for diabetics in particular.

I see your point--taken in that light (ignoring the diabetes aspect), findings are intriguing.

Might be the way the article was written: the emphasis seemed to be that sugar management is unimportant, as long as heart attack and stroke are minimized.

Controlling blood sugar accomplished little, but the simple three-drug combination would cut heart attacks and strokes by 71%.

If I understand this study correctly, patients didn't have their sugars controlled. This study seems to ignore other long-term issues of uncontrolled sugars, such as diabetic neuropathy(affect of high sugar on nerves), ulceration, retinopathy, etc.

By not controlling blood sugars, the risk of atherosclerosis, peripheral vascular disease, etc. is increased, in spite of taking the 3 generic drugs.

Dew:

Your scam indicator appears to be good for the less well known biotechs. Certainly useful for a cursory review of an unknown biotech stock.

However, it isn't perfect, as both RPRX and PPHM (possible scams?) have Biotech Values Board on their hangout lists.

Also, for some reason, CVM now lists Biotech Values Board, where it didn't last week.

"(95%) I am making up a number".

You are. Try typing in the symptoms/appearance of a "simple" rash to a program and see what you get.

"So most primary care physicians are now relegated to gate keepers of the HMOs and prescriber of pills."

Perhaps there are some PCPs who don't care anymore, because they are overwhelmed with the paperwork required to document, get paid, refer patients, and avoid litigation.

However, I'd bet that the majority of PCPs still care and are more like good detectives/educators that try to get to the bottom of what ails their patients with the least expense/time and explain these complex medical problems in layman's terms to their patients, who have much less education on average.

"inneficient in nearly all areas where it's paid for by the insurance company"

Absolutely...

On the toolbar at the top of investorshub pages, click on the "Hot!" button. Clicking on "Buzz Cloud" lists the most searched for tickers in the last 24 hours.

Interesting that on this list are such beauties as CVM, CTIC, HEB, and GVBP (among ~50 stocks). This list to me implies very active traders watching the ticker of their favorite momo stocks very closely.

I.e., those that follow these stocks are not the type of investors that are nearly as interested in the fundamentals, science or integrity of the company as they are in penny moves in the stocks.

Would You use the Search tool to search for the keyword "BioMedReports" in Public Messages??

Perhaps something in the financials?

CVM: Details about the workings of the drug have been hard to find, but medical experts say that the fact that the treatment has caught the attention of the FDA and CDC, speaks volumes about it's efficacy.

LMAO!