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>> …do you know if the UCLA study Dr. Levitt mentioned in August has anything to do with the independent studies he mentioned today? <<
No, they are not related. The UCLA stuff has do with early-stage Squalamine research in prostate cancer. The independent validation Dr. Levitt mentioned on today’s webcast pertains to the completed clinical data in AMD. Regards, and welcome. Dew
Why data validation?
>> To me their first priority (which Levitt mentioned today) should be the independent verification of the testing to date. To me this validation is the "deal maker"!!! <<
If we assume that GENR does not need independent validation the phase ½ Squalamine data for its own internal use, the only possible recipients of the validated data are: 1) Regulatory bodies such as the FDA; and 2) prospective partners.
The FDA (and corresponding agencies in other countries) likes to see clinical data validated by an independent body. But, to my knowledge, the FDA’s interest in such validation is limited to pivotal trials (i.e. trials which may result in submitting an NDA/BLA if successful).
Since the phase ½ trial just completed was clearly not pivotal, that eliminates rationale #1 above. So we are left with rationale #2: the data validation is for a prospective partner or partners.
Here I go again with my predilection for odds making: the revelation that GENR is submitting the Squalamine data for independent validation makes the probability about 95% that GENR already has at least one company waiting in the wings to partner on Squalamine. GENR and the prospective partner or partners may yet disagree on the money terms, of course. But I think it is safe to say that there is some very serious interest out there.
More on dosing/scheduling:
>> It appears that the 25 mg dose is more than enough, so a dosing regimen would probably not be needed for the study.<<
We have agreement on this key point! I feel more confident in this assertion knowing that we are on the same wavelength.
My hunch is that GENR could even go lower than 25mg/m2 and still get efficacy in AMD. However, there is no need to go lower because the 25mg dose is well-tolerated. Moreover, the animal studies on Squalamine incorporated the 25mg dose, so it is advantageous to preserve the relevance of this animal data for the eventual NDA package.
>> In the upcoming phase 2 it seems that they should try a maintenance dose of one month for some patients, and 2 months for another group, of course the people getting the maintenance every 2 months would get a placebo, at the in -between months. <<
Such a design would produce a useful comparison provided that: 1) The trial is fairly large; 2) The patients are assigned randomly into the two arms; 3) The evaluators are blinded to the treatment assigned to a given patient. These design features (especially the first one) make for a more expensive trial, and that is the reason I remain skeptical that GENR will embark on such a study without a partner.
>> I have the feeling that as you say, they could probably get by, with the every 2 month dosing and still beat the competition, but WHAT IF the monthly maintenance improves vision TREMENDOUSLY. Wouldn't it then be worth doing? <<
If the partner pays the bills, absolutely yes. However, if GENR were to embark on such a trial solo, it could be interpreted as a signal that Squalamine’s much touted long intracellular half-life might not be long enough after all.
I’m going to go out on a limb and say that the probability is at least 80% that GENR inks a partnership deal before the first patient in any new Squalamine trial is enrolled. Feedback welcomed.
Re: Squalamine delivery:
The idea of an alternate delivery mechanism for maintenance between IV infusions has some appeal. I.e., patients could receive an initial IV regimen of 25mg/m2/week*4, with maintenance via an alternate delivery mechanism until the next IV infusion.
This kind of hybrid regimen might allow infusions to be spaced at several months instead of one or two months, which would enhance the convenience and attractiveness of Squalamine vis-à-vis the competition.
There may be several potential delivery mechanisms for such maintenance therapy. A pill would be most convenient, of course, but the properties of the molecule may preclude this.
Note: this kind of hybrid treatment regimen, if doable at all, would be something to pursue as a supplement to the lead Squalamine studies using only the IV formulation. Such supplementary studies would not reside on the critical path to FDA approval.
--
biowatch: Why don’t you see what the gurus on the NSTK board think about intranasal delivery of this molecule? T.i.a.
Squalamine dosing and scheduling:
The comment in today’s webcast about an additional phase-2 study to test monthly retreatment was a surprise to me because monthly scheduling (after the initial weekly*4 loading dose) strikes me as undesirably frequent from the standpoint of convenience and cost/reimbursement. The Squalamine data in the completed phase ½ trial seemed good enough at 2 months and 4 months to justify a longer retreatment interval than one month.
However, the kind of phase-2 trial mentioned today is not the dose-finding trial that some posters here and on Yahoo have been calling for. To the contrary, my interpretation of Dr. Levitt’s presentation is that GENR is satisfied with the 25mg/m2 dose and further work on the dose (as opposed to the dosing schedule) may not be needed.
Comments?
rph: Interesting question about the possibility of negative ramifications from non-IV administration. Would like to hear from the biology cognoscenti on this subject. In any case, I am not aware of any indication from the company itself that GENR seriously intends to pursue alternative formulations such as nasal or transdermal.
--
Did you listen to today’s webcast. The revelation that GENR is submitting the phase 1/2 Squalamine data to an independent review panel makes me think this was requested by one or more prospective partners. In other words, the Squalamine data was so good that prospective partners wanted to be sure it was real!
Correction re Dr. Gerald Chader of the FFB: he is the chief scientific officer, not the president as stated in #108.
>> …do you believe the fact that the trials were done outside the U.S. causes them to be taken less seriously? <<
Unfortunately, yes. Wall Street types are heavily biased against trials in third-world countries. Even Dr. Ron Garren, the editor of the InvestBio newsletter who recently recommended GENR at $6.22, admitted to being skeptical of Squalamine because the phase ½ trial was conducted in Mexico.
>> Why would GENR have chosen to go this route in the first place? <<
Two reasons: 1) Cheaper; and 2) Easier to recruit patients because Visudyne treatment was not as widely available in Mexico.
Squalamine molecular structure:
A few people expressed an interest in Squalamine’s structure, so I’ve extracted the slide from GENR’s pdf file which shows it (#38):
Do we have any medicinal chemists in the house?
Yes, the absence is because GENR's Squalamine trial was done outside the U.S.
>> Somewhat concerned that the Foundation Fighting Blindness website does not include any information on GENR's recent clinical trials with Squalamine. I see many others mentioned, including one for Combretastatin that is currently recruiting. Any logical reason for GENR's absence? >>
The Combretastatin trial is cited by FFB’s website because it is currently enrolling patients. Closed clinical trials conducted in the U.S. may also be listed for reference purposes.
When GENR has an AMD trial in the U.S.undergoing patient recruitment, FFB will list GENR’s trial too.
P.S. Dr. Chader, the president of FFB, spoke at GENR's Aug 4 CC.
8,000 hits!
>> I have been monitoring [this board] for a couple of days now and am impressed. <<
I, too, am gratified with the response. On Tuesday (through midnight ET) this board had about 2,600 “hits,” i.e. 2,600 messages read by all readers. This brings the total hits since Saturday to approximately 8,000.
I surmise that a significant minority of these 8,000 hits were from iHub people not previously familiar with GENR.
SPA's and home runs:
>> One parting PARS comment: Your focus on the importance of an SPA implies holding till FDA approval, since improving approval odds seems to be what an SPA means to an investor. I've only been investing in biotechs for 18 months or so, and have never held till approval. Indeed, I've never held till formal application for that matter. My neophyte impression is that the hype -- and therefore profit taking -- occurs well before all those formalities. This is only based on experiences with IMCL, ABGX, and NUVO. And based on current hopes for GENR and PARS. Maybe someday I'll actually hold an issue till it generates *dividends*<<
rkcrules: Your observation is valid –up to a point. Yes, you can get doubles and triples from holding through what you call the “hype period.” Indeed, that is how I made a good deal of biotech money on the very stocks you mentioned. (As you know, I bought IMCL at $5-6 last fall, NUVO at 70-80 cents late last year, and ABGX at 4-5 early this year --all a matter of public record on the respective message boards.)
Notwithstanding the above, the relatively brief period in which you have made your biotech gains has been far from a typical period. A quick glance at the Amex biotech index during the past year is evidence that this has been a rather frothy period for biotechs in general and emerging-stage biotechs in particular. I think you will have a hard time duplicating these quick doubles and triples in a more normal biotech market.
Perhaps even more important (and staying with the baseball analogy), the way you have chosen to invest will never yield the grand slam home run into the upper deck, i.e. the 10X, 20X or even 50X gain which is achievable from the right emerging-stage biotech with some heavy-duty due diligence, a little luck, and a lot of patience.
Which brings us back to the Special Protocol Assessment (the reason this conversation began). If you are going to ride the trajectory of one of those grand slams into the upper deck, the odds are that the slugger will be a player with an SPA. Regards, Dew
Posting limit:
Using a “verified” email account when registering for iHub will allow you to make 18 posts per day instead of only three. I am not exactly sure what a “verified” email account is, but my hunch is that it is a paid account (e.g. the one that comes with your ISP) rather than a free account with a bulk email provider such as yahoo, hotmail, etc. FWIW
>> I am waiting to add after quarterly earnings news as that is only piece of confusion which can mar price. <<
Hi Swamboots, and thanks for your PM. I do not quite understand what you are driving at regarding the upcoming earnings release.
>> Will they get a chance to come up with a snappy name for squalamine, ie, squalamine is a generic name, isn't it?
More than likely, the brand name will be selected by GENR’s partner. I am partial to Seegaine, but I am concerned that Pfizer might claim trademark infringement on Rogaine
FWIW:
This board has already logged more than 1,000 message-reads today (since midnight ET), as has been the case each day beginning Saturday:
http://www.investorshub.com/boards/most_read.asp
It would appear that we are getting some reads over and above the regulars from Yahoo.
Thanks, biowatch, for another good find. A few excerpts I found notable:
Apart from laser photocoagulation of the subretinal neovascularization characteristic of the disease's exudative, or wet, form, there is no known intervention. As long as the pathogenesis remains mysterious, a specific treatment seems unlikely to emerge.
It’s astonishing how out-of-date this comment, circa 2000, now sounds.
The genetic discoveries emphasize some striking similarities between macular degeneration and Alzheimer's disease
I hope GENR longs don’t start posting that Squalamine will cure Alzheimer’s!
Of the four major causes of vision loss in persons over age 50, [AMD] accounts for more cases than the other three--cataract, glaucoma, and diabetic retinopathy--combined.
This is one of the most essential factoids for GENR investors.
Dew
It would be interesting to know if the impact of smoking on the risk of developing AMD is related either to poor absorption of the nutrients thought to be prophylactic in this disease or to “lifestyle” issues which make it less likely that these nutrients are consumed in the first place. In other words, would smokers be able to substantially reduce the risk of developing AMD by taking supplements like Bausch’s Ocuvite? [msg# 74]
>> If someone like AGN were to partner for the AMD indication, what if the NSCLC becomes viable? Would pharma sub-license it from AGN? How does one distribute indications to different entities? <<
Those are the kinds of complexities our new CFO should be able to navigate.
MBA’s know how to structure deals, and JD’s know how not to structure them. Having both degrees, the new CFO would seem to be eminently qualified for the task at hand.
Drug licenses according to indications are actually fairly common. Probably the most prominent example is Epogen/Procrit; the former is marketed by AMGN to dialysis patients, and the latter is marketed by JNJ to cancer patients.
Good find.
[From the same article]:
>> Dr. Gerald Chader, chief scientific officer of The Foundation [Fighting Blindness] remarked, “Contrary to the common misconception that AMD is merely a consequence of aging, this remarkable discovery proves that genetics can play a defining role in the disease.”<<
That’s the Dr. Chader who spoke prominently at GENR’s August 4 CC on the 2-month Squalamine data.
>> Possible risk factors [for AMD] include: genetics, cataracts, smoking, hypertension, sun exposure, farsightedness, light skin or eye color, and a diet low in vitamins, minerals and antioxidants. <<
Pretty exhaustive list, which suggests as you said that no one has a really good handle on the risk factors.
However, Bausch & Lomb is making some decent money selling an anti-AMD supplement called Ocuvite:
http://www.bausch.com/us/vision/products/vitamins/ocuvite_lutein.jsp
“ Especially formulated for people at greater risk of age-related eye conditions. Ocuvite is the #1 brand recommended by eye care professionals."
FWIW
>> does AMD run in families? <<
ichthus: That’s a great question which, to my knowledge, no one on the GENR message boards has asked. Let’s all see if we can find the answer. Regards, Dew
>> I noticed during the sign up that iHub offers a live chat feature as well, but I was unable to find it and see no reference to it in the FAQ. Perhaps, if it can be found, this feature can give those interested in discussing the real time trading of the stock a proper forum where it won't disrupt the threads. <<
Welcome, Richter. I haven’t used online chat, but I’ll try to find out about it. Could be useful for the purpose you mentioned. Dew
>> The implication is that Allergan may still be seeking a GENR partnership, even though they're already "committed" on AMD. <<
Based on the CC, AGN’s commitment to the Oculex technology of biodegradable implants seems to be rock solid, and was the rationale for the Oculex buyout.
However, the Oculex platform has reached mid-stage trials only in macular edema –not in AMD. Moreover, AGN barely even mentioned Panzem, the drug AGN licensed from ENMD almost two years ago to use with the Oculex implant in AMD. That suggests to me that the Panzem AMD program has either been shelved or has been shunted to the back burner.
Tidbit from AGN/Oculex CC:
In last week’s conference call to announce Allergan’s acquisition of Oculex, Allergan’s CEO, Davis Pyott, said this (about 13 minutes into the call):
“Our real challenge is sorting through all these different opportunities and seeing which ones we can fund… and of course we continue to look to external things and, frankly, if we find something that’s better than what we’ve got, we will basically throw one of the babies out of the boat and take the new one in…”
http://www.shareholder.com/agn/medialist.cfm?id=&largeText= [second link down]
Hmm...
>> [katie to drbio]: Definitely on the same page as you regarding Phase II <<
I’m on a slightly different page. I think GENR and partner can use the SPA procedure to try to proceed directly to phase 3 while ascertaining up front whether such a plan meets the FDA’s requirements for approval.
>> I don't blame them for pursuing this [SPA] strategy. <<
katie: I would turn your statement around and say that I will blame any company which does not secure an SPA for a pivotal trial. And I probably will not invest in such a company.
The SPA is the greatest thing to come along in quite a while for investors in emerging-stage biotechs. It will now be easier for investors to separate the companies with excellent prospects (e.g. GENR) from the companies which are little more than hyped research projects at the expense of unsuspecting shareholders.
>> Does anyone know of the chemical structure of squalamine? <<
It’s shown on slide #38:
http://www.genaera.com/AMD_4%20Mo_Slides_10.07.03.pdf
Selected slides from GENR’s Squalamine program:
Below are eight slides that I find especially noteworthy. (The complete set of slides can be found at: http://www.genaera.com/AMD_4%20Mo_Slides_10.07.03.pdf ):
Slide 17: Overview of competing therapies (Macugen, Lucentis, Squalamine):
Slide 18: Comparative efficacy at 2-3 months of the same three drugs:
Slides 29-31: The awesome market potential of drugs to treat AMD:
Slide 40: Squalamine’s mechanism of action:
Slide 50: Squalamine efficacy at 4 months:
Slide 52: Efficacy at 4 months stratified by dose. This is an especially important slide because it suggests that the 50mg/m2 dose did not work appreciably better than the 25mg/m2 dose:
[End]
Clarification on posting limits:
>> …are you concerned about the impact of the limiting number of posts per day? <<
enigmatic: When I originally answered your question, my reply contained some erroneous information. I have posted for over a year on such boards as TMTA and INTC without any daily limit on my message count. On the INTC board, I once asked the board moderator about this and he just told me not to worry about it.
However, the GENR board does not yet have an official moderator, and hence the iHub daily limit on posting will be enforced for now. (I have asked iHub to become a moderator and am waiting for a reply.)
In the meantime, you can relax the limit on the number of daily posts by registering for iHub using a “real” email account rather than a free email account at a site such as yahoo or hotmail. Doing this increases your daily allotment from 3 to 18 posts, which should be more than sufficient. Dew
The Special Protocol Assessment:
katie, drbio, et al: It is my expectation that GENR and its partner-to-be will deal with the vagaries of the FDA by submitting a Special Protocol Assessment (SPA) for the phase-3 Squalamine trial(s) in AMD.
An SPA, once endorsed by the FDA, becomes a binding contract which assures FDA approval if the safety and efficacy endpoints of the trial(s) are met. As such, the SPA process is akin to a miniature, compressed version of the FDA’s NDA/BLA approval process.
To fully understand SPA’s, please read this:
http://www.fda.gov/cder/guidance/3764fnl.htm
To steal an old cliché about the internet, when it comes to working with the FDA, the SPA changes everything!”
By way of background, I loosely follow a great many drug and biotech companies –not with sufficient DD to own them but rather to stay abreast of trends affecting the industry. SPA’s have been gathering momentum in recent months and are on the verge of becoming de rigueur for all high-risk pivotal trials. By exploiting the SPA process, several small biotechs are embarking on phase-3 trials earlier in the clinical development program than they might have been willing to do without the “cover” of an SPA. I see no reason why GENR and partner will not adopt these same tactics.
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Regarding the alternate delivery mechanisms drbio referred to, I think those studies would be highly desirable, provided that they are done in parallel with the pivotal phase-3 trials using the existing delivery mechanism.
Frank: the Lomucin results were not bad. But there was insufficient evidence to say that they were good.
To use a courtroom analogy: if you were on the jury you would certainly not vote to convict. However, you were not fully convinced that the defendant was innocent. What you really wanted to do was vote “not proven” (which I have heard is a juror’s prerogative at criminal trials in Scotland).
--
I think Lomucin is on temporary hold until GENR’s money situation becomes clarified. When we get a partnership for Squalamine, the up-front cash may be sufficient to restart the Lomucin program, with or without continued funding from the CF Foundation. JMHO. Dew
Follow-up on PPL data in CF:
Thank you, drbio, for the posts about the PPL drug candidate in emphysema and CF. I have extracted the tabular data from PPL’s phase-2 study and presented it below to illustrate just how bad this data was.
At all but the highest dose of 250mg/day, efficacy was essentially no better than placebo:
TABLE 1:
NUMBER OF EXACERBATIONS AS A PERCENTAGE OF THE PLACEBO RATE
All Exacerbations Severe Exacerbations
Dose Group % of placebo p-value % of placebo p-value
250 mg/day 75% 0.21 48% 0.08
125 mg/day 81% 0.35 94% 0.85
62.5 mg/day 106% 0.88 104% 0.91
Dose Group VC FVC FEV-1
250 mg/day 4.3 1.2 2.1
125 mg/day -0.1 -1.2 0.1
62.5 mg/day -1.8 -2.3 -0.6
Looking for help on how to enter a table in a fixed-width font. T.i.a.
A few metrics:
As of this moment, this message board is the 4th most active board today among iHUB’s 1,786 message boards, based on the number of posts:
http://www.investorshub.com/boards/most_post.asp
and it is the 17th most active board today in terms of posts read:
http://www.investorshub.com/boards/most_read.asp
The above link says that 1,157 post-reads have been made on this board today, a number which sounds incredible but must be true because iHUB tracks these metrics 24/7 in real time. In other words, this board is generating significant exposure for GENR among general iHUB members.
FWIW
>> The character entry field limited me to 20 characters so the whole thing wouldn't fit. <<
That’s funny because I completely forgot about the 20-character limit on handles. The outcome is not bad, however, as “enigmatic_anomaly” has an impressive ring to it.
Are you, per chance, an oncologist or involved with oncology in some way?
>> Regarding should they do another [dose-ranging study], the current study results show an effective dose with no recorded serious side effects/drop outs. These results surely would indicate that they may have already found the "best" dosing range. <<
That’s my contention. Higher doses than 25mg/m2/week do not appear to increase efficacy, and lower doses would seem to have little utility because the 25mg dose is well-tolerated.
I can envision additional dose-finding studies for Squalamine being done in parallel with pivotal phase-3 trials. However, it seems hard to justify holding up the start of phase 3 to wait for the outcome of such studies.
Would definitely like to hear some more educated opinions on this subject.
Apropos to “me-too” drugs:
[Thanks to biowatch for this find]:
http://www.seniors.gov/articles/0502/medicine-study.htm
>>
Majority of New Medicines Approved in the 1990s
Were Altered Versions of Older Drugs
Two-thirds of the prescription drugs approved by the Food and Drug Administration (FDA) between 1989 and 2000 were modified versions of existing medicines or identical to drugs already on the market; about one-third were drugs based on new molecules that often treat diseases in novel ways. And only 15% of drugs approved during the period both used new chemical compounds as their active ingredients and were deemed by the FDA to provide significant improvement over existing medicines, a new study finds.
The study, by the National Institute for Health Care Management (NIHCM) Foundation, also found that the bulk of the increase in spending on new prescription drugs between 1995 and 2000 was on medicines the FDA did not designate as priority for review.
The study's findings were cited in an hour-long ABC News Special on prescription drug issues —"Peter Jennings Reporting - Bitter Medicine: Pills, Profits and the Public's Health" — aired on Wednesday, May 29 at 10:00 p.m. EST.
The study found that the FDA approved 1,035 drugs in the period 1989 to 2000; 361 (35%) were new molecular entities drugs based on new chemicals acting in new ways to treat a disease. The remaining 674 drugs (65%) contained active ingredients that were already available in previously approved drugs.
The FDA further subdivides the prescription drugs it reviews into "priority" and "standard" categories. Priority drugs are put on a swifter review track because they are deemed —based on the available research —to provide significant clinical improvement over existing medicines. The NIHCM Foundation analysis of FDA data found that of the 361 drugs categorized by the FDA as new chemical entities between 1989 and 2000, 153 (15% of the total 1,035 drugs approved) were designated as priority drugs; the remaining 208 were put on a standard review track.
Of the 674 drugs that did not contain a new chemical entity, 583 received a standard rating for review and 91 received a priority rating. Thus, overall, between 1989 and 2000, 24% (244) of the 1,035 drugs the FDA approved were categorized as priority drugs with promise of significantly improved efficacy and/or safety. And 76% (791) were categorized as standard drugs.
"Highly innovative drugs are rare," says Nancy Chockley, president of the NIHCM Foundation. "This does not mean that many of the incrementally modified and improved drugs the FDA approves don't benefit patients. Some are of enormous benefit. But our findings, based on the FDA's own classification systems, puts into perspective the dynamics of pharmaceutical innovation. The plain fact is that many new drugs are altered or slightly changed versions of existing drugs, and they may or may not be all that much better than what's already available. Consumers should be more aware of that."
The study found that as the 1990s progressed, the number of incrementally modified drugs (IMDs) the FDA approved grew at a faster pace than drugs based on new molecular entities (NMEs). In the six-year period 1995-2000, the FDA approved 304 new standard incrementally modified drugs versus 168 in the period 1989-1994, an increase of 81%. By contrast, approvals of priority new molecular entities increased by just 10%, from 73 between 1989 and 1994, to 80 between 1995 and 2000.
Of the 219 more IMDs and NMEs approved in the period 1995 to 2000 compared to the period 1989 to 1994, 156 (71%) were incrementally modified drugs and 63 (29%) were new molecular entities.
The study also examined trends in pharmaceutical spending on innovative versus incrementally modified drugs from 1995 to 2000. In the retail marketplace for drugs, spending on prescription drugs doubled from $64.6 billion in 1995 to $132 billion in 2000. Of this $67.4 billion increase, $44 billion can be attributed to increased spending on drugs approved by the FDA between 1995 and 2000. (The remainder was spent on drugs approved before 1995). Increased spending on standard-rated medicines accounted for 67% ($29.3 billion) of that increase. Increased spending on priority-rated drugs with new chemical ingredients accounted for 33% ($14.7 billion) of the $44 billion increase in spending.
The study found that new drugs of all types were priced much higher than the older drugs they replaced. In 2000, the average retail price per prescription for drugs approved before 1995 was $37.20. In contrast, priority-rated new molecular entities cost an average $91.20 per prescription. New standard-rated incrementally modified drugs cost an average $65.07 per prescription. And priority-rated incrementally modified drugs cost an average $142 per prescription (primarily because of the inclusion in this category of some very expensive HIV/AIDS drugs).
The study, Changing Patterns of Pharmaceutical Innovation, attributes the trend it identifies to several structural factors in the industry. In particular, modifying an older drug enables a brand drug company to extend its intellectual property protection on the product. Such extensions, in turn, enable a brand company to delay generic competitors and maintain a high price for an aging product.
The NIHCM Foundation is a non-profit organization whose mission is to promote improvements in health care access, management and quality.
<<
>> Wouldn't [Squalamine] phase 3 take up to a year for results? <<
Longer. Here are a couple of recent Yahoo posts which speak to the issue:
http://messages.yahoo.com/bbs?action=m&board=7077012&tid=magn&mid=25769&sid=7077012
http://finance.messages.yahoo.com/bbs?.mm=FN&board=7077012&tid=magn&sid=7077012&acti...
>> Seems to me a partnering would be needed for that [phase 3] time period. <<
Agree. I think the desirability of submitting an SPA (as discussed in the above link) makes it even more clear that a partner must be on board at the outset of the phase-3 planning.