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Drifting lower until the next news item. Skyrocket for a week, then return slowly over a month or two, to only a slightly higher trading range.
Blane, do you have a link to something that was said that indicates the NIH says the 1st line therapy is about to (or might) change ? I can't imagine that, but that would be priceless.
Thanks Dakota, that would make a big difference. If that does explain all of the first 12 weeks, then most of the drop-outs are NOT Pro-140 related.
Page 12 chart *STARTS* with 40. Most of them drop out because their viral load was not suppressed.
Cytodyn investor presentation from February
http://content.equisolve.net/cytodyn/media/a142a8575db88331c0585a336ca2ebfd.pdf
Misio I, I thought it was 11 out of 40
For a patient group that already has a low viral load wasn't there less than 1/3 of patients that maintained that low figure ? Why switch to something if your drugs already have the virus under control ? Only if the side effects of HAART are becoming debilitating, might doctors prescribe Pro140. That's still a decent number, but not as high as I'd like.
The monotherapy should be done in 2016. And this was updated in February.
https://clinicaltrials.gov/ct2/show/NCT02175680?term=cytodyn&rank=1
Personally, from what i've seen so far, I am kinda pessimistic about the monotherapy, but positive about the adjunct. The adjunct is a "slam dunk", IMO.
Interesting, 8 out of 14 biggest volume days in last 12 months have been since March 28th.
CYDY could have been on one of the exchanges months ago. CYDy could also have applied for BreakThrough Designation with FFA. I believe both those decisions were mistakes, but hopefully small ones.
insert-text-here
Reqs for NASDAQ listing : 1. Pre-tax earnings ? No. 2. Aggregate cash flow of $27.5 Mill ? No. 3. Market Cap of $850 Mill ? That would require a price of $5 at 170 Mill shares.
CYDY isn't going to make that.
Reqs for NYSE listing : insert-text-here
Standard 1 ? No income. 2 and 3 Stockholder equity ? No. 4. I think CYDY can qualify under #4 which requires a share price of $3.
I'm guessing today was an intraday peak until the next news comes out. The very wide range today was like the day of the Dr Oz / Charlie Sheen program. That marked the peak and trading settled down until the ASM Microbe news. Plus the Relative Strength poked well above 70, just like then. However, if volume stays over or near 1 Million, we should go higher. Just my thoughts.
I was thinking CYDY's volatility in share price might be another reason TO HAVE a split ? It depends on the nature of the price requirement. Is the share price a "floor" of $4 that must be maintained, or or ceiling of $4 that must be poked through occasionally ?
You are correct; others have missed something
Recent run-up in last five days corresponds to a 5 to 18% run-up in large cap bios. Some, but not all, of CYDY's run-up is sector driven. What fraction ? I have no idea.
Personally, I plan to sell based on a CYDY market cap of 4 to perhaps 10 X's revenues of PRO-140. This will be at least $2 Billion X 4 or $ 8 Billion / 250 Mill shares = 32 per share; I would take 25. There is still ..... 2,360 % upside even from $1.30 !!!! But what if .... $5 Billion revenue X 10 sales ? 200 per share ??? Not going to count on that, but that could happen assuming no more than 250 Mill dilution.
Accumulation /Distribution line is soaring. ??
What I don't understand is, why doesn't Gilead buyout CYDY for a cheap $300 Mill today, rather than waiting for a few quarters or years when they might have to pay several Billion ? After June 20th, all of their scientists will know all about PRO 140. I hope any suitors wait until FDA approves 140 before they try to make a buyout.
If PRO 140 is not approved, then CYDY is worth less than $50 Mill. Or even zero.
$5 Bill. market cap BEFORE FDA approval ? No, no, that's too optimistic. With little news,(so far anyway) no cash and no approved drug ? IMO, CYDY mkt cap will still be less than $ 1 Bill (@ 175 Mill shares) in that time frame. Nonetheless, I am still very-long.
Price target in the next two years, with a multi-billion dollar drug and a 4 X sales valuation would mean at least an $8 Bill market cap. This translates to a $32 share price with a 250 M shares outstanding. My rough conservative estimate.
All the bios were up yesterday, especially the smallest caps. General bio-fund purchases could explain it, not necessarily CYDY specific news, unfortunately.
Yeah, that's whats supposed to happen. I really don't believe that anyone spends time watching and listening and *comprehending* such things has much money to invest, or works for someone who has money to invest in such companies. Perhaps I am jaded. Its so easy to over-estimate Wall Street's analytical ability.
There's still some doubt, but I think they will do a study for BTD.
"In regards to our application for Breakthrough Therapy Designation for PRO 140 for HIV, we received a response from FDA. The FDA indicated that the agency concurs with CytoDyn that treatment experience for patients who have developed resistance against prior HIV regimen meet the criteria for a serious or life-threatening disease or condition, which would warrant a Breakthrough Designation.
However, the FDA indicated that CytoDyn’s previous studies were not in the specific patient population that the Breakthrough Designation for PRO 140 was applied for. Therefore, CytoDyn needs data from that specific population that the Breakthrough Designation was applied for in order to be granted that Breakthrough Designation.
The company now could plan and to initiate a small study in HIV resistant patients to specifically address FDA’s comments.
Please keep in mind, our current combinational therapy Phase 3 and monotherapy Phase 3 trials are both in different populations than for which the Breakthrough Designation was applied. Again, this delay on Breakthrough Designation does not have any bearing in our two current trials, monotherapy and combinational therapy, and could be addressed if we do conduct a small trial in the specific patient population and submit to the agency the appropriate data."
BTD is an all-hands-on-deck approach by FDA to review. Also it is supposed to be applied for in the early clinical phases. Not usually in Phase 3. I understand your negativity, but I have positive feelings mixed in with that about what will happen this afternoon.
What are the benefits of BTD?
For drug manufacturers, it is about the intensity and frequency of their interactions with FDA. Once the designation is granted, the FDA takes an “all hands-on-deck” approach to providing the manufacturer with ongoing guidance and feedback throughout the clinical development process. Products that receive BTD are also able to submit portions of their marketing application on a rolling basis (rather than all at once at the end of clinical trials) and BTD can also be used in combination with other expedited programs in order to further reduce the product’s time to market.
Conference call will provide "an update on clinical and regulatory developments". Plural. Guesses ? Breakthrough for adjunct HIV or Orphan designation for GvHD, or both ? Or something else ?
The 8-K is upping the number of shares to 250 Million.
No FDA news would be bad news, IMO. CYDY would be issuing a press release or two, otherwise.
75 cents will be hit, just as .....somebody said on this board.
This aggressive schedule is only possible with a Break Through Designation. We should hear something about that before March 23
$1 Bill in revenue for PRO-140 adjunct + $1 Bill in revenue for PRO-140 monotherapy (perhaps more) times a conservative 4 X's revenue = $ 8 Billion in buyout. Even if diluted to 250 M shares, that would be $32 a share.
The math would be unaffected by the reverse split. The prices go up by the same factor that the number of shares go down; GET OVER IT !!
I still *think* this is genuine, but I have a bad feeling about this. Pourhassan's Ph D is in Engineering, not medicine.
Excited about publicity on Dr Oz show but ....
this feels like something a "pump and dumper" would do. I'm sorry, I'm long the stock and hoping it will pop this week, but this makes me wonder about the credibility of Dr Pourhassan and Cytodyn.